Microbiologist at Fresenius Kabi

Description

• 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