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Results for microbiology in Jobs in Cape Town
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The successful candidate will report to the Technical Manager, responsibilities will include the following:
Job Responsibilities:
Responsible for all the laboratories (Analytical & Microbiology) equipment & reagents – liaise with old/new suppliersEnsure that Laboratories (Analytical & Microbiology) stock levels are managed within the required budget.Drive annual calibration of all laboratory testing equipment including daily verification and calibration of equipmentAdhere to FSSC 22 000 guidelines and continuous implementation of GLPAssist in Annual Capex application + motivationIdentify resource requirements in the microbiology and analytical laboratory. (e.g., the need for new equipment, upgrading of current equipment or the need for more equipment)Annual ring testing/inter lab testing to verify process equipment reproducibility and personnel repeatabilityDrive the isolation system. Including communication, analytical testing, problem solving, decision-making and statistical trendingResponsible for the warehouse investigation system. Including communication, analytical testing, destructive packaging testing, root cause identification, decision-making and statistical trendingPresent food safety data concerning quality control at the monthly & annual food safety meetingsDrive the E-Mark/SANS 1841 system and E-mark AuditsEnsure that daily quality report is completed, with the focus on quality control, and communication to all relevant departmentsEnsue that daily GMP photo report are completed and communicated to all relevant departmentsAssist with the food safety management system (FSSC 22 000 & ISO 9001) including gap audits, internal and external auditsDrive the concession systems and communication of concession summary to the NPD departmentCo-ordination and improvement of corrective & preventative action systems.Daily product quality evaluations and follow up actionHandling & investigation of customer complaints, drawing up reports, statistical trending, and corrective action implementation.Personnel Management
Required qualification and experience
Food Technology Diploma or Food Science Degree3 Year Laboratory experienceKnowledge of GLP, HACCP & ISO
Other Attributes would include:
Ability to communicate effectively at all levelsAbility to troubleshootExcellent computer skillsExcellent administrative skills and accuracySelf-motivated and result driven approach
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8xODg3MjA5MzEzP3NvdXJjZT1ndW10cmVl&jid=1695470&xid=1887209313
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Reporting to the Food Technologist – Micro
Job Duties & Responsibilities
Applying all micro procedures.Preparation of agars.Sterilization of micro equipment and area.Sampling, testing and plate counting of all micro samples according to procedures.Weekly CIP micro tests to evaluate effectiveness of cleaning according to procedure.Micro testing of final products after shelf life.Always ensure tests are completed accurately.Maintenance and cleaning of equipment in micro lab.Recordkeeping of all micro results and daily equipment verification.Assistance with shelf-life studies.Assistance with scheduling and completing monthly sterilization tests for lines.Timeously report OOS (Out of Specification) results and deviations to supervisor.Apply 5-S principals in workplace.Assists with incoming inspection when needed.Ensure accurate traceability of raw materials and final product.Assist with GMP and Internal audits.Ad-hoc tasks requested from time to time by the supervisor/department head.
Our ideal candidate must have:
Qualifications – National Diploma Food Technology/ BSc Food ScienceExperience 1-2 yearsBasic course in Microbiology
Other attributes:
AccuracyAble to work independentlyAble to do routine work every dayComputer skillsWork under pressureAble to prioritize workload
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8zMzI3NDk4Nzc4P3NvdXJjZT1ndW10cmVl&jid=1695468&xid=3327498778
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QUALIFICATIONS NEEDED
Tertiary Qualification in Microbiology / Biotechnology / Life Science / Pharmacy or equivalent
NECESSARY EXPERIENCE & INDUSTRY ACCREDITATION / KNOWLEDGE
At least 6 years’ experience in the pharmaceutical / biotech manufacturing industryAt least 3 years’ experience in a Training Management / Facilitation positionExperience in quality management systems within a cGMP facility
KEY DUTIES & RESPONSIBILITIES OF THE ROLE
Plan and coordinate GMP training activities and requirements according to project plans and site requirementsPrepare, review and coordinate GMP training procedures, processes and systemsIdentify risks, investigate / troubleshoot cGMP non-compliance issuesNotify relevant department manager regarding issues of non-conformance and recommend corrective actionsProvide coaching on training requirements and GMP needs to Managers and siteProvide technical support for drafting of GMP modules along with Subject Matter ExpertsSource training material from external vendorsDevelop GMP training templates and customize training material where requiredSubmission of monthly reports and feedback on effectiveness of trainingRisk mitigation plans for staff who are not ‘licensed’ to perform their work functions due to failed assessmentsEnsure that all GMP training audits are successful in with Standard Operating Procedure requirementsContinuous improvement of the training system in line with industry trends and cGMPOverall accountability for the Trackwise Training System
Should you meet all the requirements and wish to apply, please send your latest CV and motivation to diane@abcworldwide.com
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8xOTcwNDU2MTA1P3NvdXJjZT1ndW10cmVl&jid=1328341&xid=1970456105
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QUALIFICATIONS NEEDED
Bachelors or higher degree in chemistry/biotechnology/pharmacy/engineering or equivalent
NECESSARY EXPERIENCE & INDUSTRY ACCREDITATION / KNOWLEDGE
Good working knowledge of aseptic (sterile) manufacturing processesAt least 10 years of process, equipment and project design and execution experience within the sterile pharmaceutical /biotech manufacturing industryExperience in managing and executing multi-disciplinary projects in excess of R100 millionExcellent understanding of process flows and key metrics within a sterile manufacturing environmentExcellent understanding of the cGMP guideline relating to sterile productsExperience in initiating, planning, executing, and closing projectsExperience in the control and monitoring of project progress and risksIndependent decision makers, able to debate and lead change managementAble to lead conceptual design regarding processes/ equipment/ structural design etc. Microbiological knowledge essentialPrevious project work and proven ability to convert guidelines into design specs
KEY DUTIES & RESPONSIBILITIES OF THE ROLE
Ensures that projects are properly scoped with clearly defined deliverables and clear execution plansTo execute the full range of technical project activities including design, scoping, budgeting, scheduling and execution for successful delivery in line with organisational requirementsTo develop technical standards and user requirement specificationsIdentify and escalate risks and mitigation/recovery plansCreate project budget and ensure adherence to the prescribed budgetRequest approval for changes from necessary stakeholders and manage changes via project change request processesEnsure that the quality criteria is properly defined for each deliverable and frequently measured and reportedEnsuring all designs are cost effective and value adding for the companyExecute/provide technical advice for process and or equipment processesConduct manufacturer visits to perform design reviews, risk analysis, FAT as well as receive training from manufacture for the relevant equipmentCompile the necessary documentation upon completion of manufacturer visit and trainingConduct the necessary research in order to contribute towards ensuring that the process equipment (new equipment) is qualified (IQ, OQ) and ready for production activities within the project timelinesProcess equipment SOPs, specifications, qualification documents and MBRs are generated through the appropriate review process and in place for production within the required timelineEnsures that the project delivery is in line with agreed Sterile Products c...
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8xNTU3MzY5MzQ3P3NvdXJjZT1ndW10cmVl&jid=1188027&xid=1557369347
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QUALIFICATIONS NEEDED:
Bachelor’s Degree or Diploma in Microbiology / Biotechnology/Engineering/Chemical, Pharmacy or equivalent.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE
At least 5 years’ experience within the pharmaceutical/ biotech/API manufacturing industry.Technical and process knowledge in controls for aseptic manufacturing, inspection, packaging and manufacturing process principles. Understanding of process to manage and coordinate the implementation of changes within a manufacturing facility as a function of the Quality Management System.Understanding of Project management principlesInteraction and understanding of quality role in the dynamic pharmaceutical manufacturing environment. Sound application of risk management and technical report writing.Understanding of Validation & Qualification principles, Quality by design principles.Quality and Regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO as well as application.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
Independently participate in projects and Technical activities as QA SME as defined by QAO Manager Participate in projects and ensure project deliverables delivered as per agreed timelines and quality. Key decision maker on quality aspects of allocated projects.Participate and perform independently as a key component to the wider project team.Where required, participate and drive with other project team members to ensure the delivery of the required key deliverables.Ensure quality by design, risk-based approach and risk assessments conducted and mitigated where appropriate in accordance to project timelines.Ensure Change management, Risk management are incorporated into all allocated projects Ensure projects integrate into the Quality management systemReview and Approval of all operational documents and records in the projects e.g. System and Component Impact Assessments, GMP reviews, Design Qualification, IQ, OQ, PQ, functionality testing, Aseptic Process Validation, Process Validation, Analytical Method Validation, Cold-chain Packaging validation and Cleaning Validation documents, including both Protocols and Reports to ensure compliance with site approaches, cGMP and regulatory agency requirements.Ensure compliance to quality systems is monitoredAssist QA Operations team where SME input is requiredIntroduction and coordination of QMS principles as a key component of cGMP in the design and development of expansion facilities and the associated new technologies.Drive understandin...
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8zMDIyMDIxNT9zb3VyY2U9Z3VtdHJlZQ==&jid=377096&xid=30220215
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Qualifications required:
Degree or diploma in Engineering / Natural Sciences / Microbiology or equivalent.
Necessary Experience and Industry Accreditation/Knowledge
At least 5 years’ experience in pharmaceutical/ biotech manufacturing industry.At least 1 to 2 years’ experience at junior to Senior Management level.Experience in quality management systems within a cGMP facility.
Key Duties and Responsibilities
Management and mentorship of Senior Validation Scientists, Validation Scientists and Validation Interns.Ensuring that Validation requirements are achieved at the required quality and regulatory levels (Company, SAHPRA, WHO, pharmacopoeia) and within the agreed timeframes.Conduct section planning and execute activities within own scope of accountability.Ensure adequate capacity planning and performance delivery in line with strategic, tactical and operational plans.Role profiling, goal setting and performance management of Validation staff within the section.Review and/or update high level validation and qualification guidance documents, such as VMP, VPs, SOPs.Attend and participate on technical and projects strategic meetings/discussions involving internal and external stakeholders.Assist in execution of routine qualification activities i.e. Equipment / Utility / Facility, Systems, CSV and Data Integrity.Review and approves protocols and reports for all process validation activities based on company standards/guidelines, procedures, andIndustry current practices.Reporting on key operations, critical numbers and key performance indicators that impacts the section’s short, medium- and long-term objectives.Conduct effective and comprehensive costing, budgeting and expense management for own section, taking all overlapping site activities into consideration.Lead own section’s transition into commercial operations and mind-set as well as managing efficiencies, reducing wastage and contributing to overall profitability.Ensure execution of process validation activities including Process Development, Process Validation, Cleaning Validation, Cold Chain and Ongoing Process Verification.Participate in Process Automation and Data Management activities including Data Integrity and CSV.Report timeously on validation progress and status to the Validation Manager.Ensure and or assist system/ equipment owners with identifying maintenance and calibration requirements.Ensure relevant OOS and OOT investigation non-conformances/ deviations, change controls and CAPA’s are initiated and completed.Tracking and expediting the review and sign-off of validation documentation.Writing / guiding the ...
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8zNzEwMTYzMzQ1P3NvdXJjZT1ndW10cmVl&jid=1295734&xid=3710163345
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QUALIFICATIONS NEEDED
? Degree or Diploma in Microbiology / Biotechnology, Pharmacy or equivalent
NECESSARY EXPERIENCE & INDUSTRY ACCREDITATION / KNOWLEDGE
? At least 5 years’ experience in Quality Assurance within the pharmaceutical/ biotech/APImanufacturing industry Sound technical ability in the field of operational Quality Assurance? Experience in Quality Management Systems within a sterile manufacturing cGMP facility? Quality and Regulatory compliance knowledge, i.e. SA GMP, PIC/S and WHO as well as application.Project management in Quality Assurance? Sound application of Risk Management and technical report writing? Understanding of Validation & Qualification principles, Quality by design principles
KEY DUTIES & RESPONSIBILITIES OF THE ROLE
• Review and approve minor and major deviations and escalate critical deviations to the manager• Review and approve CAPA in order to meet compliance requirements• Review and approve minor and major change controls for quality and regulatory compliance impactand determine requirements for implementation• Coordinate and participate in risk assessments and ensure mitigations are efficacious whenapplicable• Review and approve SOPs and Work instructions for responsible areas• Review, approval and sign-off all operational documents and records, e.g. periodic re-qualification,periodic-revalidation including both Protocols and Reports to ensure compliance with siteapproaches, cGMP and regulatory agency requirements• Act as a QA lead on critical deviations, investigations, Risk assessments and Root cause Analysis asrequired• Ensure that the activities in the Quality Assurance Department are achieved at the required qualitylevels (SA GMP, PIC/s and WHO). Analyse and write annual trend reports where applicable.• Support Quality Assurance with customer audits, Regulatory audits and other 3rd party audits;perform internal and supplier audits and compile audit reports; assist HOD and Manager on followup and close out of audit findings timeously.• Ensure compliance to all applicable regulations and internal procedures by proactively interpretingregulatory and quality requirements and determining way of working
• Participate in achieving the company’s quality objectives• Participate in building a sustainable quality culture on site and proactively mitigate risks that maynegatively impact quality or escalate these appropriately• Ensuring audit readiness within own role through closing out audit findings timeously. Participate inprojects as / when required• Ensure project deliverables delivered as per agreed timelines and quality. Key decision maker onquality aspects of allocated projects• Ensure quality by design, ris...
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS8xOTY3Mzk4NDE0P3NvdXJjZT1ndW10cmVl&jid=377097&xid=1967398414
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Qualifications Required:
Degree or diploma in Engineering / Natural Sciences / Microbiology or equivalent.
Necessary Experience and Industry Accreditation
At least 5 years’ experience in pharmaceutical/ biotech manufacturing industry.At least 1 to 2 years’ experience at junior to Senior Management level.Experience in quality management systems within a cGMP facility.Good Engineering Practice and understanding of ISPE guide.
Key Duties and Responsibilities
Management and mentorship of Senior Validation Scientists, Validation Scientists and Validation Interns.Ensuring that Validation requirements are achieved at the required quality and regulatory levels (Company, SAHPRA, WHO, pharmacopoeia) and within the agreed timeframes.Conduct section planning and execute activities within own scope of accountability.Ensure adequate capacity planning and performance delivery in line with strategic, tactical and operational plans.Role profiling, goal setting and performance management of Validation staff within the section.Review and/or update high level validation and qualification guidance documents, such as VMP, VPs, SOPs.Attend and participate on technical and projects strategic meetings/discussions involving internal and external stakeholders.Ensure execution of routine qualification activities i.e. Equipment / Utility / Facility, Systems, CSV and Data Integrity.Review and approves protocols and reports for all qualification activities based on company standards/guidelines, procedures, andIndustry current practices.Reporting on key operations, critical numbers and key performance indicators that impacts the section’s short, medium- and long-term objectives.Conduct effective and comprehensive costing, budgeting and expense management for own section, taking all overlapping site activities into consideration.Lead own section’s transition into commercial operations and mind-set as well as managing efficiencies, reducing wastage and contributing to overall profitability.Assist in Process Development activities including Process Validation, Cleaning Validation and Cold Chain.Participate in Process Automation and Data Management activities including Data Integrity and CSV.Ensure execution of qualification processes: FAT, Commissioning, SAT, DQ, CIA, SLIA, IQ, OQ, PQ and PRQ as per defined timelines and cGMP and report timeously on qualification progress and status to the Validation Manager.Ensure and or assist system/ equipment owners with identifying maintenance and calibration requirements.Ensure relevant OOS and OOT investigation non-conformances/ deviations, change controls and CAPA’s are initiated and completed....
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS85MTMxNDg1NjA/c291cmNlPWd1bXRyZWU=&jid=1295733&xid=913148560
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Our client is looking for a Junior Food Safety Officer to join their team.
Duties and Responsibilities
Document controlResponsible for procedures and monitoring formsSorting, storing and retrieving electronic and hard copy documentsProducing document progress reportsConducting internal auditsLabelling templates and spec sheetsCommunication at key times to facilitate food safety
Skills
Good administration skillsThoroughness and attention to detailAble to work well with others
Qualifications
BSc/National Diploma in Food Technology/MicrobiologyMinimum 2 years experience in an FMCG environment focused on food safetyHACCP and FSSC 22000 experience would be an advantage
https://protool.gumtree.co.za/external-link-browser.html?url=aHR0cHM6Ly93d3cuZGl0dG8uam9icy9qb2IvZ3VtdHJlZS80MDIwODA0ODg1P3NvdXJjZT1ndW10cmVl&jid=375218&xid=4020804885
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