Fresenius Kabi Manufacturing SA (PTY) LTD

Eastern Cape, South Africa


Sep 8

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, incubators.Assist in training of new laboratory assistants, environmental samplers, production personnel and microbiologists as required.Analysis of Pharmaceutical 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.Assess raw materials and final products for bacterial endotoxins when necessary.Perform specialised microbiological testing in the lab (i.e. Antibiotic and biological assays, disinfectant efficacy, growth promotion test).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 on biological indicators from Ethyle Oxide and steam 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

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