The Laboratory Technologist performs microbiological quality control testing to ensure the safety, sterility and microbiological compliance of a recombinant anti-tick vaccine manufacturing process, including sterility testing, environmental monitoring, bioburden assessment and microbiological support for potency and facility compliance under GMP.
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Laboratory Technologist - Microbiology (3 Positions)New!
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National Vaccine Production Centre (NVPC)
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Description (Public)
Duties, Roles and Responsibilities
- Perform routine and batch-release microbiological tests including sterility testing by membrane filtration or direct inoculation, bioburden testing and microbial limits.
- Prepare and qualify microbiological media, reagents and growth promotion tests.
- Conduct environmental monitoring of classified areas including active air sampling, settle plates, surface monitoring and personnel monitoring.
- Trend environmental monitoring data and support investigation of excursions and action level breaches.
- Accurately document all microbiological testing activities in controlled records.
- Monitor preventive maintenance, calibration and qualification of quality control instruments and equipment.
- Participate in deviations, OOS and OOT investigations, root cause analysis and CAPA implementation.
- Participate in validation and verification of microbiological methods.
- Ensure compliance with pharmacopoeia and regulatory requirements for microbiological testing.
Qualifications, Education and Competencies
Qualifications & Experience:
- Bachelor's degree in Science Technology Biology, Microbiology, Biomedical Sciences or a related life science discipline.
- A master's degree in any of the above fields is an added advantage.
- Hands-on experience in sterility testing laboratories, environmental monitoring programmes, aseptic techniques and microbial culture and identification.
- Familiarity with cleanroom classifications and environmental monitoring trending.
- Knowledge of the European Pharmacopoeia, ICH and WHO GMP guidelines.
Skills & Competencies:
- Aseptic technique and cleanroom discipline.
- Microbiological testing and media preparation.
- Data trending and record keeping.
- Attention to detail.
- Investigation and root-cause analysis.
How to Apply
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