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Head of Regulatory Affairs (POS24078)R 1,8mill per annumBased in MidrandBEE Candidates only to applyJob Purpose:The Head of Regulatory Affairs holds ultimate responsibility for the RX DIVISIONS regulatory activities and oversees the development and delivery of a fully integrated regulatory strategy for the business.Requirements Qualifications:To ensure legal compliance with the relevant Health Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act 101 of 1965, as amended and South African Pharmacy Act (Act 53 of 1974), and other relevant regulationsQualifications: B. Pharm Degree Registration with South African Pharmacy Council.A minimum of 8 years pharmaceutical regulatory experience is an absolute prerequisite.Minimum of 5 years in people or team management is required.This role requires a high degree of networking & collaboration both within and outside the organization.Demonstrated experience across the product development, commercialization and dossier maintenance lifecycle Key Job OutputsDrives the regulatory process to ensure timely filing of new products and variations in accordance with business and compliance objectives.Adopts a risk-based assessment for all regulatory submissions and anticipates potential issues for risk mitigation strategies to be in place.Anticipates future regulatory changes and impacts on business success.Communicates to ensure an excellent understanding of Regulatory AffairsPays strict attention to details and accurately monitors and measures progress towards objectives and provides feedback on results whilst maintaining sense of urgency.Strives to maintain a high level of quality. Ensures superior execution by combining the best practices of regulatory.Represent RA at operational meetings such as Technical Transfer, QA, Operations, Launch, Artwork/ Packaging, Stability and Research & Development, where proactive input can then enhance operation efficiency.To give information and input to Responsible Pharmacist in order to facilitate appropriate decision making in order to ensure that all SAHPRA requirements are timeously met.Manage the regulatory and compliance aspects of any project launched into operations including acquisitions and mergers, as well as technical transfer projects.Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.Internal Training, Development and Mentorship to the Rx RA ManagersEstablish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders.Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.Manage activities such as internal audits or regulatory agency inspections.Manages a team in the Relicare India TeamTo collaborate and support the Group Regulatory Affairs function in achieving the company regulatory strategic objectives and goals.Closing Date: 30
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly9lbi16YS53aGF0am9icy5jb20vY29vcG9iX19jcGxfX18xMTA4XzE4MDc0MF9fNDk3P3V0bV9zb3VyY2U9Z3VtdHJlZSZ1dG1fbWVkaXVtPWZlZWQma2V5d29yZD0=&jid=1786380&xid=1108_180740
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Surgo (PTY) Ltd. has partnered with one of South Africas fastest-growing pharmaceutical retail groups with operations in South Africa, Botswana, and Namibia. The group was founded in 1978 and has its Head Office based in Midrand, Johannesburg.
Our client has since grown to over 200 stores to date, employing over 18 500 full-time and part-time employees and is now looking to recruit an Organisational Development Manager to join their team.
Job Purpose:
Strategic implementation of organisational development activities through research, design, development, and facilitation of OD interventions to optimise the alignment of the workforce and key business strategies and initiatives.
Responsibilities:
Organisation Design:
• Strategic organisational design through understanding organisational structures and job specific requirements to contribute to the HR Strategy of the company
• Conduct job analysis and evaluations and development of job profiling
• Implement and maintain job grading system
• Create competency model Performance Appraisals and Management
• Identify performance targets and link with job profile
• Develop methods of measuring if performance management aligns with organisational goals
• Develop, review, and implement performance management policies and procedures
• Guide management on performance appraisal and management principles
• Assist management to create project timelines and deadlines Workforce and Succession Planning:
• Design and implementation of succession planning in line with companys talent management framework
• Guide management on succession and career development to ensure the sustainability of the business
• Provide input into employee risk movement and develop strategic plan to ensure higher retention rate
• Develop, review, and implement succession planning policies and procedures
• Evaluate job satisfaction and corporate culture through climate surveys and develop and implementation action plan to prevent high employee turnover
• Design and implement competency-based assessment and analyses
• Compile appropriate test batteries for different assessment purposes and according to competency requirements
• Obtain quotes from suppliers when required and consider costing when suggesting assessments
• Interpret results obtained from assessments and utilise information in an ethical manner
• Provide feedback on assessment results to relevant members of the HR team, Department Heads as well as respondents
• Utilise the information obtained from assessments in order to suggest and implement relevant HR interventions Leadership Strategy: (Wellness)
• Facilitate team building, group forming, strategic planning, and training sessions to ensue cohesive functioning of teams
• Diagnose potential organisational problem areas and liaise with management to implement strategies counter concerns
• Conflict Management within teams
• Design and implement leadership strategies in line with business obje...Job Reference #: 202621
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LetsLink Medical Recruitment Agency is assisting one of the leading health insurance product providers in South Africa to employ a Call Centre Agent to work in the Gap Cover department.
Requirements to apply:
1 year or more relevant experience (Call Centre) Customer Service training FAIS Compliance (RE5 Certificate) is essentialMatric or equivalent qualification Excellent English communication (verbal and written) Ability to manage large amounts of inbound calls in a timely mannerCustomer Service skillAttention to detail Resilient: must be able to work under constant measurement and pressureAdvanced computer skills
Salary: Salary range between R1k and R15k per month
Working hours: Normal office hours
How to apply: Interested candidates who meet the above criteria are requested to e-mail a detailed CV to vacancy@letslink.co.za or to contact Gary on +27(0)110261907
Please view our website: www.letslink.co.za LetsLink is a registered recruitment agency, specializing in placing all staff in the Healthcare, Medical and Pharmaceutical sector.
By applying for this position and providing us with your CV and other personal information, you are consenting to the information being used for the specific purpose for which it was provided, which is recruitment purposes and possible appointment purposes (Should you be successful). Please note that your information will be processed for recruitment purposes only or for such purposes relating to assessing the establishment of the employment relationship with yourself, and this will be done in accordance with the applicable data protection and privacy legislation. We confirm that such information will not be used for any other purpose without your prior consent. If your application is not successful, we retain your CV and other information provided for a period of 24 months after which it will be destroyed in a secure manner. If you object to your information being used in accordance with the aforementioned clauses, please indicate your objection and we will immediately destroy your personal information in a secure manner.
https://www.ditto.jobs/job/gumtree/334552044?source=gumtree
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A private hospital group based in the Gauteng region is seeking to employ an Infection Control Coordinator to aid and assist the hospital employees in the management of prevention, identification, and control of infections in patients and employees. The successful candidate will be responsible to plan, develop and implement an infection control Program for the hospital using infection control standards and international best practice.
Minimum requirements:
Registration with the South African Nursing Council as a registered Nurse/Midwife or equivalent NQF7 qualification.Relevant qualification and 2 years’ experience within a specialist area.An Infection control related qualification would be preferred.Advanced Computer Literacy.Capacity to implement and maintain standards of health practice required from all accredited bodies and appropriate health legislation.
Key work output and accountabilities
Practice patient care according to the Scope of practice of the Registered Nurse.Maintain an up-to-date infection control file that is available and accessible to all nursing and house-keeping staff.Ensure the provision of protective clothing for all staff and members of the public.Include infection control in -service training.Communicate effectively with staff regarding their care.Investigate and monitor all injuries on duty claims.Audit of health records to ensure compliance.Ensure all stock is well controlled and managed, charged and credited appropriately.Promote and maintain good public relations with patients, relatives, and visitors.
Desired Skills:
Registered NurseInfection Prevention and Control experience and knowledgeHealth and safety experience and knowledgePrivate hospital experience is an advantage
Desired Work Experience: 2 to 5 years
Salary: Salary range between R25k and R35k per month
How to apply: Interested candidates who meet the above criteria are requested to e-mail a detailed CV to vacancy@letslink.co.za or to contact Gary on +27(0)110261907
Please view our website: www.letslink.co.za LetsLink is a registered recruitment agency, specializing in placing all staff in the Healthcare, Medical and Pharmaceutical sector.
By applying for this position and providing us with your CV and other personal information, you are consenting to the information being used for the specific purpose for which it was provided, which is recruitment purposes and possible appointment purposes (Should you be successful). Please note that your information will be processed f...
https://www.ditto.jobs/job/gumtree/3439954450?source=gumtree
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A top company in the pharmaceutical industry is seeking an Enthusiastic, energetic and professional Receptionist with great communication skills. The candidate must have strong proficiency in both English and Afrikaans.
Purpose
You will be the first point of contact for visitors and callers, representing the organization in a professional and friendly manner. You will play a crucial role in maintaining an organized and efficient office environment.
Key Responsibilities
Greet and assist visitors with a warm and professional demeanor.Manage incoming calls, redirect them to the appropriate staff, and take messages when necessary.Maintain a tidy and welcoming reception area.Provide administrative support to various departments as needed, including data entry, filing, and document preparation.Assist in scheduling and organizing meetings, appointments, and events.Maintain and update records, databases, and filing systems.Assist in the preparation and organization of reports and documents.Respond to inquiries via phone, email, or in-person, providing information and assistance.Draft and proofread routine correspondence and emails.Monitor and control access to the premises, ensuring the safety and security of the office.Issue visitor badges and maintain visitor logs.Assist in data management tasks, including data entry, data retrieval, and data organization.Handle multiple tasks simultaneously and efficiently prioritize work.Adapt to changing priorities and respond to urgent requests.
Requirements
Must have Matric.Must have at least 2 years experience in a receptionist or administrative support Must have strong proficiency in both English and AfrikaansMust be Proficient in Microsoft Office Suite (Word, Excel, Outlook).Must have Strong communication skills, both written and verbal.Must have Excellent organizational and time management skills.Must have Attention to detail and accuracy in all tasks.Must have ability to maintain confidentiality.Professional appearance and demeanor.
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8xNTE3MjE4OTI/c291cmNlPWd1bXRyZWU=&jid=1748731&xid=151721892
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Providing best practice day-to-day manufacturing pharmaceutical services to manage workflow, production and document procedure compliance so as to ensure safe and efficacious medicines are manufactured.
Qualifications and Experience:
Pharm DegreeRegistered with South African Pharmacy CouncilPreferably 2-3 years’ experience in Pharmaceutical Production in a Manufacturing environmentcGMP skillsComputer Literacy – MS Office (proficient in Excel, Word and PowerPoint)
Outputs:
Lead training on SOP, departmental inspection, and audits (both internal and external)Online and in line testing resulting in approval of batch documentation and Provisional releasesSubmission of full production manufacturing tickets and supporting documentation within 24 hours of batch completionsAbility to identify, execute and prioritize work tasks/projectsExcellent interpersonal, communication skills and collaborativeStrong problem solving and troubleshooting capabilitiesImprove production efficiency and reduce overtimeProper documentation of manufactured pharmaceutical productsPerform Line Openings and Closures in manufacturing linesPrepare weekly production scheduling of productAuditing batch documents for QA closure and releaseAssist in preparing Annual Product Quality ReviewsInitiate, investigate and close off CAPAs and Non-Conformances.Ensure regulatory compliance Safety, Health and Environmental Standards.Oversight on manufacturing process including in-process checksRegulatory and document complianceHandling of non-conforming production, both inbound, WIP and produced batchesAudits and continuous improvement capabilitiesDevelopment of team’s technical capabilitiesLead / champion change overs, line opening, line closing,Lead and be the chief accountable officer for GMP and micro compliance in the area on shift
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8zMzQxMTAzMjc2P3NvdXJjZT1ndW10cmVl&jid=1263510&xid=3341103276
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Providing best practice day-to-day manufacturing pharmaceutical services to manage workflow, production and Document Procedure Compliance so as to ensure safe and efficacious medicines are manufactured.
Key Performance Areas:
Lead / Champion change overs, line opening, line closing,Lead and be the chief accountable officer for GMP and Micro compliance in the area on shiftOnline and in line testing resulting in approval of batch documentation and Provisional releasesSubmission of full production manufacturing tickets and supporting documentation within one hour of batch completionsEnsure regulatory compliance Safety, Health and Environmental Standards.Manufacturing process including line checksRegulatory and Document ComplianceHandling of non-conforming production, both inbound, WIP and produced batchesAudits and Continuous ImprovementManaging Pharmacist AssistantsProper documentation of manufactured and packaged pharmaceutical productsPerform Line Openings and Closures in manufacturing and packing linesPrepare weekly production scheduling of productAuditing batch documents for QA closure and releaseAssist in preparing Annual Product Quality ReviewsInitiate and close off CAPAs and Non-Conformances.Development of Team’s technical capabilitiesFacilitate SOP training of all personnel in the departmentAbility to identify, execute and prioritize work tasks/projectsExcellent interpersonal, communication skills and team orientedStrong problem solving and troubleshooting capabilities.
Minimum Requirements:
Pharm DegreeRegistered with South African Pharmacy CouncilPreferably 2-3 years’ experience in Pharmaceutical Production in a Manufacturing environmentcGMP skillsComputer Literacy – MS Office (proficient in Excel, Word, and Power Point)Competencies:
Deciding and initiating actionDelivering results and meeting customer expectationsPlanning and organisingWriting and reportingApplying expertise and technologyCoping with pressure and setbacksAchieving personal work goals and objectivesAdhering to principles and valuesRelating and networkingPresenting and communicating information
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8xNTk2MjQ4MjkyP3NvdXJjZT1ndW10cmVl&jid=1409702&xid=1596248292
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LetsLink Medical Recruitment is assisting a Private Hospital based in Gauteng to employ a Vascular Scrub Nurse.
Position Summary: The position will perform a variety of duties involved in providing patient care in a hospital theatre setting and particularly scrubbing for Vascular surgeries The candidate is required to maintain a sterile environment and high nursing standard and must have experience in treating patients who suffer from a variety of disease including artery disease, abdominal aneurysms, leaky leg veins and peripheral arterial disease.
Position Requirements:
Education: Registered Nurse Diploma/Degree or equivalent. Post Basic qualification in Theatre Nursing is an advantageSANC RegistrationExperience: Previous vascular surgery theatre scrubbing experience is essential, Cath Lab scrubbing is advantageous
Interested candidates who meet the above criteria are requested to e-mail a detailed CV to vacancy@letslink.co.za or to contact Gary on +27(0)110261907
Please view our website: www.letslink.co.za LetsLink is a registered recruitment agency, specialising in placing ALL staff in the Healthcare, Medical and Pharmaceutical sector.
By applying for this position and providing us with your CV and other personal information, you are consenting to the information being used for the specific purpose for which it was provided, which is recruitment purposes and possible appointment purposes (Should you be successful). Please note that your information will be processed for recruitment purposes only or for such purposes relating to assessing the establishment of the employment relationship with yourself, and this will be done in accordance with the applicable data protection and privacy legislation. We confirm that such information will not be used for any other purpose without your prior consent.
If your application is not successful, we retain your CV and other information provided for a period of 24 months after which it will be destroyed in a secure manner. If you object to your information being used in accordance with the aforementioned clauses, please indicate your objection and we will immediately destroy your personal information in a secure manner.
https://www.ditto.jobs/job/gumtree/1642796781?source=gumtree
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You will be responsible for supervising team members in their specific Packaging areas. Setting and maintenance of machines. Ensuring that packaging processes are carried out according to specified procedures and methods.
Qualifications and Experience
Trade Tested Artisan (preferably N6 Mechanical, Fitting or Mechatronics), Diploma in Mechanical/Mechatronics Engineering, or related qualificationAt least 3 - 5 years’ experience with high volume machinery in Pharmaceutical Manufacturing or FMCGCore Competencies:
Technical aptitudePharmaceutical cGMP knowledgeKnowledge of Oracle will be an advantageDeciding and initiating actionLeading and supervisingWorking with peopleAdhering to principles and valuesPresenting and communicating informationWriting and reportingPlanning and organisingDelivering results and meeting customer expectationsAdapting and responding to changeCoping with pressure and setbacks
Key Performance Areas:
Provide comprehensive shift performance by filling the performance sheet “SIC” accurately with all the required details and update Halden at the end of shiftLead and actively participate in MBU1 meetings and processesEnsure that team members that are returning after an unplanned absence have had the necessary return to work interview, brought the necessary documentation and completed the requisite leave forms on the first day of the employee’s return to work.Ensure lunch break of the team is within allocated timeEnsure that the team minimises all kinds of wasteEnsure that no Packaging activities are performed under non-compliant environmental conditionsPerform daily verification of All the scales/balances in the area before commencing with packaging activitiesEnsure that no out-of-calibration scale is used in the areaEnsure that any out of calibration equipment is visibly labelled as such and removed from the area where possibleLiaise with the Shift Leader and the manufacturing to ensure that packaging materials are available timeously for packagingBefore any packaging processes are started, ensure that ALL the packaging materials are checked, that quantities and identification are correct for ALL the packaging materialsEnsure that the packaging document is endorsed with signatures and dates promptly as the process occursEnsure that good documentation practices are followed and maintained as packaging activities are being performedEnsure that packaging activities are performed in line with the MPDR process instructionsPromptly report any observed safety incidents or risks to the S...
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS80NDI2MzE3MDY/c291cmNlPWd1bXRyZWU=&jid=1409703&xid=442631706
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To support the overall Validation Program by conducting qualifications and preparing and/or executing validation documents. This includes the generation, development, modification, and routing of Validation Protocols, Final Reports, Standard Operating Procedures, and Change Controls. Validation systems are in place and used to control/ guarantee the quality of products.
Responsibilities of the Role:
Execute-validation documentation in line with the standard approval process/protocolsMaintains matrices for all departmentsCommunicate and liaise with all stakeholdersImplement process improvement initiativesPerform root cause analysis of system failuresUpdating existing quality documentationIdentifying training requirementsMaintains accurate and complete safety /GMP records with company policy and legal requirementsAdministers troubleshooting efforts for protocol discrepanciesIdentify process gaps and apply process improvement methodologiesPlan, prioritize process improvement initiativesExplores process improvement opportunitiesIdentify and communicate any skills/training requirements to help execute tasks efficiently.Develop validation documents with functional teams, ensuring the documentation meets regulatory requirements and quality standardsTo ensure that new and updated Guidelines and Policies from SAHPRA and other Regulatory bodies related to pharmaceutical industry are used at all times when developing internal documentationInterface with customers to ensure concerns and complaints are communicated and corrective actions are closed in a timely mannerTo ensure that all validation related audit points identified during audits are closed timeouslyWrite, review Protocols, Deviations, Final Reports, SOPs, and Change Controls with emphasis on process validation.
Minimum Requirements:
Bachelors Degree in Science/Engineering or a related disciplineExperience in pharmaceutical industry with the manufacturing environmentAt least 2 years in a Validation DepartmentGood working knowledge of manufacturing equipment, process, facility, utilities and computerised system validationProficiency in MS Office (Word, Excel, PowerPoint and Project management)Ability to interpret and relate validation guidelines and standards for implementation to functional areasDemonstrated ability to provide technical solutions for problems through process knowledgeProficient in the use of structured problem-solving tools such as Process Mapping, Root Cause Analysis, Failure Mode effects analysis, etc.
Core Competencies:
Presenting and communicating informationApplying expertise and technolog...
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8yNzAxMTY4MTA4P3NvdXJjZT1ndW10cmVl&jid=1322070&xid=2701168108
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To comply with cGMP, MCC guidelines, SOP’s and adhere to batch documentation instructions at all the times.
Key Responsibilities:
Ensure regulatory compliance Safety, Health and Environmental Standards.Manufacturing process including line checksRegulatory and Document ComplianceHandling of non-conforming production, both inbound, WIP and produced batchesAudits and Continuous ImprovementDevelopment of Team’s technical capabilitiesLead / Champion change overs, line opening, line closing,Submission of full production manufacturing tickets and supporting documentation within one hour of batch completionsAbility to identify, execute and prioritize work tasks/projectsExcellent interpersonal, communication skills and team orientedStrong problem solving and troubleshooting capabilitiesLead and be the chief accountable officer for GMP and Micro compliance in the area on shiftOnline and in line testing resulting in approval of batch documentation and Provisional releasesManaging Pharmacist AssistantsProper documentation of manufactured and packaged pharmaceutical productsPerform Line Openings and Closures in manufacturing and packing linesPrepare weekly production scheduling of productAuditing batch documents for QA closure and releaseAssist in preparing Annual Product Quality ReviewsInitiate and close off CAPAs and Non-Conformances.
Qualifications and Experience:
Pharm DegreeRegistered with South African Pharmacy CouncilPreferably 2-3 years’ experience in pharmaceutical production in a manufacturing environmentcGMP skillsComputer Literacy – MS Office (proficient in Excel, Word and Power Point)Competencies
Deciding and initiating actionDelivering results and meeting customer expectationsPlanning and organisingWriting and reportingApplying expertise and technologyCoping with pressure and setbacksAchieving personal work goals and objectivesAdhering to principles and valuesRelating and networkingPresenting and communicating information.
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8yNTkyMzU2MTM4P3NvdXJjZT1ndW10cmVl&jid=1263511&xid=2592356138
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You will provide clear direction, identify opportunities, and define the organizational structure of projects.
Key Performance Areas:
Identify, quantify opportunities and issues through analysis of manufacturing siteOversee production processes ensuring that production is accurate and cost-effectiveMaintain production targets by ensuring that the required documents products are delivered dailyImplementation of site efficiency reports and ensure alignment to site business improvement strategic objectivesMeasure, report and monitor efficiencies in the various departments and implement continuous improvements for efficiency improvementsConduct process improvement interventions.Ensure optimal value add to customer by delivering usable solutions to internal and external customers based on validated informationProcess improvement, such as cycle time improvement, usage of utilities, cost reduction, increase in yield, minimizing wasteIdentifying process inefficiencies and wastes of time, money, materials, and energy.Conducts studies in operations to maximize workflow and spatial utilization.Ensures facility efficiency and workplace safetyEnsuring the translation of the business operational strategy into tactical project plans to deliver both tangible and intangible results (including performance improvement, cost reduction, lead time improvement, capability building and cultural change.Manage transformation improvement projects and build capability through training and coaching, provide leadership on how to solve problems and improve performance.
Minimum Requirements:
Bachelor’s Degree/ B. Tech in Industrial EngineeringMinimum of 3 years’ experience delivering on Performance Excellence and continuous improvement methods in a manufacturing environment (Lean, 6sigma, Shingo, TPM, TQM), demonstrating tangible business impactExperience in a pharmaceutical environment would be advantageousExperience in project management will be advantageousAbility to read, write, and interpret documents such as safety rules, standard operating procedures, maintenance instructions, and procedural manualsAble to change priorities and manage multiple projects simultaneously in a fast-paced environmentComputer literate with prior experience with MS Office, Microsoft Project and general software technologiesPrevious project management experience and general management experience is necessary.
Core Competencies:
Good Technical SkillsBasic business acumenCustomer Service OrientationAble to work shifts and OvertimeG.M.P ComplianceSafety AwarenessGood MechanicalProblem solving skillshttps://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8xODA1NzAzMDQ3P3NvdXJjZT1ndW10cmVl&jid=1311352&xid=1805703047
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A top Pharmaceutical Distributor is looking for a Payroll administrator who is able to analyze and interpret data, candidate must have an eagerness to learn.
Requirements
Must have Matriculated.Must have a BCom DegreeMust have at least 1 year payroll Experience.Must have Strong Excel Skills.Must have strong Communication. Must have clear Credit.
Available to start as soon as possible.
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8zMzA5NzEwMTIxP3NvdXJjZT1ndW10cmVl&jid=1684888&xid=3309710121
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Key Outputs:
Assist with external audits were necessary; compile reports and follow-up on CAPAParticipate in risk assessments on QMS and departmental processes to assess risk and identify mitigating actions and controlsConduct root cause investigations into incidents and deviations identifying root cause and CAPAParticipate in Quality Management Reviews to identify trends in QMS processes and implement CAPAs to address any deficienciesReview and approve Master Batch Documents for compliance in line with the dossierReview Annual Product Quality Review reports and initiate CAPA’s from the recommendation of these reviewsCompile, review and approve QMS SOP’s ensuring compliance to the SAHPRA cGMP GuidelinesTrain and implement the QMS SOP’s ensuring understanding by the relevant staffReview, track and follow through on change controls, deviations and assess the impact of the change and deviation on quality systems and processesPerform and track internal audits / self-inspections of departments as per schedule, compile reports and follow-up on corrective and preventive actionControlling and assigning expiry dates for finished products on the ERP systemReview Packaging Material test reportsPrepare monthly reports on the status of deviations, change controls, corrective and preventive action, risk assessments, and reprocessesMonitor compliance with cGMP requirements in the sterile plantAudit all sterile plant batch records for compliance and releaseParticipate in validation programs, including media fillReview investigations arising from customer complaints, ensuring that complaints are thoroughly investigated, and effective corrective and preventative actions have been identified and implemented
Minimum Requirements:
Bachelor Pharmacy DegreeRegistration with South African Pharmacy Council1 years’ Sterile experience in aseptic manufacturing2 years’ QA experience within a pharmaceutical manufacturing environmentcGMP skillsComputer Literacy: MS Office (proficient in Excel, Word, and Power Point)QMS and pharmaceutical knowledgeUnderstand the requirements of the relevant Acts and regulations governing the pharmaceutical industry.
Competencies:
Deciding and initiating actionLeading and supervisingWorking with peopleAdhering to principles and valuesPresenting and communicating informationApplying expertise and technologyLearning and researchingPlanning and organizingFollowing instructions and proceduresAdapting and responding to changeCoping with pressure and setbacks
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS80MTA2MzU1NjU0P3NvdXJjZT1ndW10cmVl&jid=1211954&xid=4106355654
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To ensure that utility systems are maintained in a state of compliance and reliably performs their validated function with maximum availability to support the different production areas. Ensure that operation and maintenance requirements of critical purified water system, boiler plant, steam distribution system, electrical reticulation system, transformers, emergency generators, chilled water plant, compressed air system as well as Air Handling Units (AHU) are adhered to.
Responsibilities:
Ensure that the execution of planned preventative maintenance schedules for statutory inspections, such as boiler and lifting equipment, are prioritised.Drive continuous energy and water conservation in compliance with the company’s sustainability and environmental commitments.Participate in various quality system elements, including systems such as complaint handling, recall handling, deviation management, root cause analysis, CAPA management, change control, and quality risk management.Participating in validation activities within the area of responsibility to ensure that pharmaceutical systems such DQ, IQ, OQ and PQ are complied with as per SAHPRA and other regulatory requirements.Ensure compliance to regulatory requirements with regards to Good Engineering Practices (GEP) and current Good Manufacturing Practices (cGMP)Assist with the drafting and update of relevant departmental SOPs timeously.Oversee execution of planned preventative maintenance program on utilities equipment which includes the purified water system, boiler plant, steam distribution system, electrical reticulation system, transformers, emergency generators, chilled water plant, compressed air system and Air Handling Units (AHU), including dehumidifiers.Oversee execution of planned preventative maintenance program on equipment within the sterile eye-drops environment which includes cleanroom filling area, compounding and preparation area, Water for Injection (WFI) plant, clean steam, particle monitoring system as well as leak detection and packaging area.Arrange and manage specialist contractors to perform specific tasks that fall outside the scope of internal resources, including evaluation of alternative key suppliers.Coordination of continuous improvement initiatives to establish the root causes on recurring maintenance problems and implementing action plans to achieve long term solutions.Assist with the review and development of planned preventative maintenance (PPMs) schedules in a quest to continuously improve the maintenance system.Provide 2nd level support on equipment maintenance and breakdowns, including call-outs.Safety, Health, Environment and SustainabilityEnsure compliance with the Occupational Health and Safety Act, 85 of 1993 as amended within the area of responsibility.High Voltage ...
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8zODM4NzA1ODg1P3NvdXJjZT1ndW10cmVl&jid=1350629&xid=3838705885
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You will be responsible for supervising team members in their specific Packaging areas. Setting and maintenance of machines. Ensuring that packaging processes are carried out according to specified procedures and methods.
Qualifications and Experience
Trade Tested Artisan (preferably N6 Mechanical, Fitting or Mechatronics), Diploma in Mechanical/Mechatronics Engineering, or related qualificationAt least 3 - 5 years’ experience with high volume machinery in Pharmaceutical Manufacturing or FMCG
Core Competencies:
Technical aptitudePharmaceutical cGMP knowledgeKnowledge of Oracle will be an advantageDeciding and initiating actionLeading and supervisingWorking with peopleAdhering to principles and valuesPresenting and communicating informationWriting and reportingPlanning and organisingDelivering results & meeting customer expectationsAdapting and responding to changeCoping with pressure and setbacks
Key Performance Areas:
Provide comprehensive shift performance by filling the performance sheet “SIC” accurately with all the required details and update Halden at the end of shiftLead and actively participate in MBU1 meetings and processesEnsure that team members that are returning after an unplanned absence have had the necessary return to work interview, brought the necessary documentation and completed the requisite leave forms on the first day of the employee’s return to work.Ensure lunch break of the team is within allocated timeEnsure that the team minimises all kinds of wasteEnsure that no Packaging activities are performed under non-compliant environmental conditionsPerform daily verification of All the scales/balances in the area before commencing with packaging activitiesEnsure that no out-of-calibration scale is used in the areaEnsure that any out of calibration equipment is visibly labelled as such and removed from the area where possibleLiaise with the Shift Leader and the manufacturing to ensure that packaging materials are available timeously for packagingBefore any packaging processes are started, ensure that ALL the packaging materials are checked, that quantities and identification are correct for ALL the packaging materialsEnsure that the packaging document is endorsed with signatures and dates promptly as the process occursEnsure that good documentation practices are followed and maintained as packaging activities are being performedEnsure that packaging activities are performed in line with the MPDR process instructionsPromptly report any observed safety incidents or ...
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8yODQwMzcxMDQzP3NvdXJjZT1ndW10cmVl&jid=1409701&xid=2840371043
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Provide technical support to all departments in accordance with established Service Level Agreements and company standards.Responsible for ensuring that qualification of utilities is carried out in accordance with manufacturing procedures and policies, cGMP, and relevant guidelines.Generate, execute and/or review completed qualification protocols and associated data for conformance to applicable acceptance criteria.Coordinate timely completion of utilities qualification in support of manufacturing activities and Regulatory requirements (writing, reviewing and execution of qualification protocols and reports).
Minimum Requirements:
Bachelor’s degree Mechanical/ Electrical Engineering /Biotechnology /BiochemistryExperience in pharmaceutical industry experience, with at least 3 years in Validation/ Qualification/ Utility supportKnowledge of HVAC, Water for Injection, Purified Water, Compressed Air and Clean Steam and Nitrogen systemsDemonstrate ability to provide technical solutions for complex problems through qualification knowledge.Proficient in the use of structured problem-solving tools such as Process Mapping, RCA (Root cause analysis), FMEAs (Failure Mode effects analysis) etc.In depth understanding of utilities and engineeringExcellent communication and interpersonal skillsAbility to work independentlyOvertime from time to time will be required so flexibility will be important.
Core Competencies:
Relating and networkingPresenting and communicating informationWorking with peopleDeciding and initiating actionDelivering results and meeting customer expectationsPlanning and organisingWriting and reportingApplying expertise and technologyCoping with pressure and setbacksAchieving personal work goals and objectivesAdhering to principles and values
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8yNjA1OTEwMTk0P3NvdXJjZT1ndW10cmVl&jid=1245770&xid=2605910194
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To maintain all training matrices and training records of all laboratory staff, drawing up of protocols for analyst qualification, preparing annual laboratory training plan and reviewing and assessing all training assessments. To ensure that testing errors are eliminated by ensuring testing is performed by trained and competent personnel.
Qualifications and Experience:
Maintaining of documentation for the analyst qualification as per CL-GQC-GEN-013.Prepare annual Laboratory SOP training PlanScheduling of SOP Training session according to approved training plan.Communicate with the section managers and supervisors on training plans and ensuring that required attendee attends training sessions.Preparation and execution of analyst qualification.Maintaining of the Analyst qualification matrix.Making sure all updated SOP’s training is scheduled and doneMaking sure training matrix is updated (maintaining of training matrix).Making sure the register is completed for all training attended and maintain the accurate training registers.Assessing, reviewing and marking all training assessments.
Qualifications and Experience:
BSc Degree Microbiologist/ Chemistry /Diploma in Biotechnology or equivalent4 or more years’ Pharmaceutical QC Laboratory experienceTraining experience an advantageKnowledge of Quality Management SystemsUnderstanding of Quality Control, Good Laboratory Practice guidelines and firm understanding of GLP requirements for generated data integrityComputer literacy – Microsoft Word, Excel, Outlook, and PowerPointLaboratory testing techniques and knowledge in chemistry/microbiology laboratory and instrumentation used in both chem and micro laboratory.Competencies:
Leading and supervisingWorking with peopleAdhering to principles and valuesPresenting and communicating informationWriting and reportingApplying expertise and technologyPlanning and organisingDelivering results and meeting customer expectationsAdapting and responding to changeCoping with pressure and setbacks
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS80MTE3MjkwNT9zb3VyY2U9Z3VtdHJlZQ==&jid=1426220&xid=41172905
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LetsLink Medical Recruitment is assisting a Private Hospital based in Johannesburg Northern Suburbs to employ a Vascular Scrub Nurse.
Position Summary: The position will perform a variety of duties involved in providing patient care in a hospital theatre setting and particularly scrubbing for Vascular surgeries The candidate is required to maintain a sterile environment and high nursing standard and must have experience in treating patients who suffer from a variety of disease including artery disease, abdominal aneurysms, leaky leg veins and peripheral arterial disease.
Position Requirements:
Education: Registered Nurse Diploma/Degree or equivalent. Post Basic qualification in Theatre Nursing is an advantageSANC RegistrationExperience: Previous vascular surgery theatre scrubbing experience is essential, Cath Lab scrubbing is advantageous
This is an opportunity for you to join a fast growing very exciting top Privat hospital that is expanding into the new normal post COVID. there is an extremely supportive Management Team that is focused on the wellbeing of their patients and staff. If you are a Vascular Scrub Nurse and are seeking to grow your career into vascular/Cath Lab nursing then this opportunity is for you.
Interested candidates who meet the above criteria are requested to e-mail a detailed CV to vacancy@letslink.co.za or to contact Gary on +27(0)110261907
Please view our website: www.letslink.co.za LetsLink is a registered recruitment agency, specialising in placing ALL staff in the Healthcare, Medical and Pharmaceutical sector.
By applying for this position and providing us with your CV and other personal information, you are consenting to the information being used for the specific purpose for which it was provided, which is recruitment purposes and possible appointment purposes (Should you be successful). Please note that your information will be processed for recruitment purposes only or for such purposes relating to assessing the establishment of the employment relationship with yourself, and this will be done in accordance with the applicable data protection and privacy legislation. We confirm that such information will not be used for any other purpose without your prior consent.
If your application is not successful, we retain your CV and other information provided for a period of 24 months after which it will be destroyed in a secure manner. If you object to your information being used in accordance with the aforementioned clauses, please indicate your objection and we will immediately destroy your personal information in a secure manner.
https://www.ditto.jobs/job/gumtree/862441133?source=gumtree
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LetsLink Medical Recruitment is assisting a Private Hospital based in Johannesburg Northern Suburbs to employ a Neurosurgery Scrub Nurse.
Position Summary:
The position will perform a variety of duties involved in providing patient care in a hospital theatre setting and particularly scrubbing for Neurosurgeries. The candidate is required to maintain a sterile environment and high nursing standard.
Position Requirements:
Education: Registered Nurse Diploma/Degree or equivalent. Post Basic qualification in Theatre Nursing is an advantageSANC RegistrationExperience: Previous Neuro Scrubbing experience is essential
This is an opportunity for you to join a fast growing very exciting top Privat hospital that is expanding into the new normal post COVID. there is an extremely supportive Management Team that is focused on the wellbeing of their patients and staff.
Salary: Our client will consider all qualifying candidates
How to apply: Interested candidates who meet the above criteria are requested to e-mail a detailed CV to vacancy@letslink.co.za or to contact Gary on +27(0)110261907
Please view our website: www.letslink.co.za LetsLink is a registered recruitment agency, specialising in placing all staff in the Healthcare, Medical and Pharmaceutical sector.
By applying for this position and providing us with your CV and other personal information, you are consenting to the information being used for the specific purpose for which it was provided, which is recruitment purposes and possible appointment purposes (Should you be successful). Please note that your information will be processed for recruitment purposes only or for such purposes relating to assessing the establishment of the employment relationship with yourself, and this will be done in accordance with the applicable data protection and privacy legislation. We confirm that such information will not be used for any other purpose without your prior consent.
If your application is not successful, we retain your CV and other information provided for a period of 24 months after which it will be destroyed in a secure manner. If you object to your information being used in accordance with the aforementioned clauses, please indicate your objection and we will immediately destroy your personal information in a secure manner.
https://www.ditto.jobs/job/gumtree/792233879?source=gumtree
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