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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
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PRODUCT MANAGER HUAWEI - SERVER, STORAGE & CLOUDReporting to the Brand Director, the successful candidate will be based in Midrand and will be responsible for the following:KEY RESPONSIBILITIES• Business Strategy Development and Execution• Understand the development strategy for the vendor and implement in SBM sector? Increase customer coverage/count for vendor and Pinnacle? Increase vendor product coverage for vendor? Increase geographic coverage for vendor• Define and document a development plan with each partner and focus on the execution• Review the plan every quarter• Present status of the development plan back to vendor• Training and up-skilling of partners and Pinnacle• Development partner to grow sales and presales resources of partner• Training on vendor sales tools• Training on vendor processes and systems• Managing minimum certification level of partners• Involving partners in vendor training and events• Ensure operational excellence of vendor within the partner• Orders are placed on vendor timeously• Quotes are fast and accurate• Credits are passed by vendor and to reseller/partner• ETA and delivery information• Escalation of partner operational issues at vendor and focus on resolution• Alignment of vendor resources to partner• Making sure that stakeholders at the vendor interface with stakeholders at the partner at the following levels:? Technical? Presales? Sales? Management? Marketing• Working with the partner to drive marketing initiatives on behalf of the vendor, these initiatives may include? Marketing events? Tele-campaigns? Internal incentives? Promotion of vendor events? Driving vendor GTM’s with the partner and ensuring focus on the GTM’s• Managing the vendor sales process• Deal registration• Discount Management• Lobbying support for partner at the vendor• Margin management (ensuring the integrity of channel pricing)• Vendor sales funnel management & reporting funnel to vendor• Enlisting vendor support to drive opportunity to closure• Vendor relationship management• Making sure that relationships are maintained with key vendor contacts that are required to be successful quarterly review for the partner• Solution focus for each partner• Vendor focus for each product• Take ultimate responsibility for the revenue target allocated to the partner• Drive Pinnacle product focus within each respective partner• Be the custodian of the vendor relationship at the partner• Ensure that vendors’ products are top of mind with all key stakeholders within the partner• Analyze market segments and develop marketing strategies to build product demand by creating effective solutions and awareness of the product and brand• Pro...
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The Business Unit Manager’s function has the mandate to establish a relationship between the product and the business and to increase the value realized from capital invested in the brand. The Business Unit Manager is responsible for understanding the business, assisting in the prioritization of projects, ensuring that projects align with the technology that provides maximum return on investment, and directing the various brands in strategically supporting the overall business strategy. The Business Unit Manager is the liaison between sales and the business unit and a trusted advisor to the business unit. As such, the Business Unit Manager needs to have significant knowledge in subject matters pertaining to Business solutions/HP and must have a thorough understanding of the business to identify its needs and envisage business solutions.Reporting to the Brand Executive, the successful candidates will be based in Midrand and will be responsible for the following:
KEY RESPONSIBILITIES• Achieve annual gross profit targets, while remaining within budgeted weeks of inventory and aged stock levels.• Manage and mentor the HPI team, including BDM’s, Product Managers, and Product Specialists• Engage closely with sales teams and sales silo managers• Engage closely and maintain a good relationship with the vendor, HP inc.• Participate in the division’s annual budgeting and planning process for the assigned business units, and track results.• Develop and manage the relationship between the Brand, internal and external partners• Conduct and execute effective business planning with internal and external Business Partners• Activate, enable, and grow Business Partnering in accordance with HP growth expectations and scorecard requirements, including marketing and demand generation• Distribution into Retail and Commercial/Public Sector channels• Build relationships at all levels within the company• Enable and facilitate technical and sales training: internal as well as partner/reseller base• Attend customer visits with your business partners• Sales funnel management – present weekly sales funnel at the weekly team meeting• Facilitate and assist with marketing events to generate leads for Business Partners• Create and promote high-impact and innovative marketing programs and initiatives with the partners to generate new opportunities
REQUIREMENTS• Matric certificate with exemption and a tertiary qualification in the field of business administration, computer science, finance, information systems, or marketing is essential• Five (5) years of related work experience in the distribution/resale channel• Experience in Business development within diverse Business Partner accounts• Analytical thinker and excellent decision-making skills• Good understanding of business acumen• Customer focused• Good interna...
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Tower Group has partnered with one of South Africas leading ICT distribution company. We are on the hunt for three experienced product managers to join their ever-expanding team.
Key responsibilities:
• Business Strategy Development and Execution
• Understand the development strategy for the vendor and implement in SBM sector
? Increase customer coverage/count for vendor and Pinnacle
? Increase vendor product coverage for vendor
? Increase geographic coverage for vendor
• Define and document a development plan with each partner and focus on the execution
• Review the plan every quarter
• Present status of the development plan back to vendor
• Training and up-skilling of partners and Pinnacle
• Development partner to grow sales and presales resources of partner
• Training on vendor sales tools
• Training on vendor processes and systems
• Managing minimum certification level of partners
• Involving partners in vendor training and events
• Ensure operational excellence of vendor within the partner
• Orders are placed on vendor timeously
• Quotes are fast and accurate
• Credits are passed by vendor and to reseller/partner
• ETA and delivery information
• Escalation of partner operational issues at
What you will need:
• Matric with mathematics is essential
• Sales and Marketing qualification and/or relevant diploma is preferred
• 2 to 3 years IT sales experience is essential, specifically on Enterprise solutions such as Servers, Storage, Cloud etc.
• Previous IT distribution experience will be an advantage
• Excellent knowledge of MS Office suite is essential
• Knowledge of CRM and ERP systems is preferred
• Knowledge of the process critical in sales e.g., RMA’s & deliveries
• Service quality orientated
• Ability to work under pressure
• Relevant technical knowledge and technology-driven
• Customer focused
• Excellent time management
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8xNTQzNzE0NjY3P3NvdXJjZT1ndW10cmVl&jid=1479560&xid=1543714667
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Our client is looking for a dynamic individual who has a good understanding and knowledge of the IT market in SA as well as the rest of Africa.
The successful incumbent will drive Sales and Business Development on various solutions and services. Solutions include Security, Hybrid Cloud as well as Data Centre solutions.
Minimum Requirements:
? Bachelor’s degree or equivalent through other qualifications/work experience
? Demonstrable solutions sales track record
? Strong background and understanding of Security, Virtualisation, Converged, Hyper Converged, Cloud/Hybrid Infrastructures and related services
? Demonstrable consultancy-led sales and business development capabilities
? Track record of meeting and exceeding annual Sales targets
Key Accountabilities:
? Company Solutions revenue growth
? Understands and further develops the companys Solutions Value Proposition
? Direct engagement with Key clients on all levels (Business, Architecture and C-levels)
? Must be able to open and close key opportunities
? Contribute to the Business Development of the companys Security, Hybrid Cloud and Datacentre portfolio
? Shares knowledge and makes a useful contribution to the knowledge base
? Stays abreast of IT industry trends related to the companys portfolio
? Establishes a CIO level business network to understand current and future needs and identify new business opportunities
? Always ensure opportunity data integrity
? Pro-active engagements with Key clients to help shape requirements and influence solutions based on client requirements
Behavioural Competencies:
? Sales and business development
? Consultancy led sales
? Analytical and strategic thinking
? Putting the customer first
? Drive for results and achieving together
? Quality focus
Professional Competencies:
? Communication skills and stakeholder management
? Ability to influence at executive level both internally and externally
? Knowledge of the company and its relevant portfolio
? Financial awareness
? Intimate knowledge of trends and technologies associated with IT Infrastructure Solutions and Services
NB: When applying - please take note of the minimum requirements i.e. Qualifications and number of years’ experience and the specific field.
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8xNzg4ODY5ODg3P3NvdXJjZT1ndW10cmVl&jid=1358978&xid=1788869887
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Our client is looking for a technical service representative with preferably a tertiary qualification in civil engineering and extensive experience in construction, quality control and knowledge of flooring products.
You will provide technical support to the sales team and clients, training and demonstrations at customer sites on correct product application, assist with product development, investigate and resolve customer complaints, keep accurate records and ensure quality control is maintained.
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8zMzA3MTY4MDA1P3NvdXJjZT1ndW10cmVl&jid=1211941&xid=3307168005
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Leading Homeware Company is looking for an experienced Business Development, Sales & Sourcing â?? Management Level
Skills and Experience:
University degree / Tertiary education
5+ years’ experience in Product Development within the Homeware sector – supply or retail - essential
Management experience required
Far East factory and sourcing experience essential
Ability to travel to Asia - must have travelled multiple times previously
Fantastic organisational skills, highly analytical with strong excel skills
Process and procedures driven and an adherence to deadlines.
Project and people management skills, able to multitask at a high level
Strong communication skills
Comfortable with managing and communicating at an executive level
A passion and energy for trends, the products and a fast-paced and innovative working environment
Responsibilities:
Be involved in all stages of the product life cycle from new product concepts, range extensions through to overseeing the production, packaging, delivery and store merchandising
Product selection and presentation – you need to find the gaps
Staying up to date with trends and processes within the Homeware Industry.
Sourcing new factories to improve existing ranges as well as new products
Management of critical path for multiple products from costings to through production and customer delivery
Attending trade fairs and supplier visits in the Far East
Negotiating with suppliers and customers
Attending meetings with customers
Working with designers and marketing to ensure great packaging
Stock management and forecasting
Store merchandising – you will be involved at all levels of merchandising
Strong Business acumen
Job Reference #: JHB001357/MP
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Lead with Impact: Shape Organizational Culture and Drive Success as our People & Culture Specialist! and a Lead with Impact: Shape Organizational Culture and Drive Success as our People & Culture Specialist!Consult with BU mangers to remain abreast of current and future business operational and tactical needsUtilise data analytics to support business insights and people practicesCustodian of the total People & Culture vale chainManage the implementation/delivery of all People & Culture value chain programmes - workforce planning, organisational design, recruitment and selection, onboarding, reward and recognition, change management, employee wellness, employee and industrial relations, payroll cost management, training, and development, succession planning and offboarding for all staff for the BU in line with group processesProvide support to People & Culture Associate (and where required lead) on disciplinary and grievance related matters for the BU, including policy compliance, procedural compliance for disciplinary enquiries and dispute resolution at external dispute resolution bodies (CCMA, Bargaining council, DoEL)Ensure the BU remains compliant to all people related legislative requirements including but not limited to skills development, employment equity, LRA, BCEA, OHSE, POPIAAdvise and coach BU management on all people related mattersInfluence and manage the BU organisational design to achieve lean organisational structures which are in line with business strategy and revenue levels.Preferred Skills- HR experience: 5+ years experience in HR role(s) in comparable organizations.- Project Management: 3-5 years experience in participating in small to medium HR related projects.- Analyse, interpret and report on data.- Presentation skills.- Translate Financial and Business outcomes into People & Culture drivers. Key Competencies- Ability to manage ambiguity.- Ability to think critically and solve for problems.- Innovative thinker.- Ability to take a long term view.- Outcomes orientated.- Ability to operate independently.- Collaborative and takes people along.- Strong interpersonal awareness.- Ability to operate with a coaching mindset. - Strong stakeholder engagement.
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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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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...
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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...
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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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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 ...
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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
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Head of IT (CIO) POS24079Based: MidrandSalary R2,700000 - 2,800000 pa + incentivesQualification & RequirementsBSc/BCom in Computer Science or related field.Minimum 10 years IT work experience required, including at least 5 years as a CIO/IT Director/IT Executive in accompany with a revenue of at least 5 billionIn-depth understanding of a tier 1 ERP systems (Oracle/SAP).Understanding of Factory Systems.Understanding of Quality Assurance and Quality Control systemsIndustry 4.0/Pharma 4.0 exposure.Pharmaceutical or FMCG sectorAttributesStrategic orientation.Ability to work independently.Understanding of Global TrendsStakeholder management and Collaboration.Function well under pressure with agile mindset.Innovation and Proactivity.High ethical standards.High Emotional Intelligence.Agility.Solution orientated, critical thinker and sound decision-making abilitiesKey OutputsIT StrategyInformation SecurityIT GovernanceBusiness Continuity, Disaster Recovery and Risk ManagementTechnology ManagementApplication Systems Management Business InformationDigital TransformationIT Project ManagementStakeholder Relationship ManagementFinancial ManagementHuman Capital Management
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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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