Microbiologist
Fresenius Kabi · Eastern Cape
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- Monitoring of micro-organisms at all stages of production to ensure the manufacturing of sterile parenteral products in compliance with laid down standards.
- Maintain a clean laboratory and cleanroom environment according to procedures.
- Preparation and sampling of all environmental samples and testing according to procedures.
- Administrative duties, such as correct and complete documentation, maintaining of logbooks, procedure updates, archiving and store maintenance FIFO.
- Ensuring correct use, maintenance and calibration of laboratory equipment e.g. air samplers.
- Assist in training of new laboratory assistants and environmental samplers as required.
- Approval and release of ETO sterilized items for use in the environmentally controlled areas.
- Analysis of Water, Bulk and raw materials for bioburden.
- Reading, interpretation and documentation of all environmental sample result swabs, contact plates, air counts, settle plates and finger dabs, water and product total viable counts and communicating any out-of-specification OOS results to relevant production and quality staff to facilitate OOS investigation, documentation and resolution.
- Administrative duties, such as filing of test results and special requests, assisting with procedure updates, archiving of old test reports, checking co-microbiologist documented calculations and procedure compliance, compiling reports or validation protocols when required.
- Performance of media fill, sterility testing, environment and water sampling and testing when necessary.
- Assist in microbiological monitoring of media fills, environmental observations and identifications.
- Active participation of microbiological related projects which are aimed at reducing OOL results both in the laboratory and production areas.
- From time to time carry out additional tasks within the laboratory that are consistent with the qualification and / or training of the incumbent.
- Assist in the microbial testing required for ETO sterilization process.
- Assist with theoretical and practical assessments of gowning competency qualifications of all FKMSA staff and active participation in the ongoing Aseptic Mentorship Program
Requirements
- B.Sc Microbiology and / or Biotechnology or NTD/HNTD Microbiology / Medical Technology
- A minimum of 1 year experience in the Microbiology field