|Company||Fresenius Kabi Manufacturing SA|
|Reference #||Micro CJ052020|
|Location||Port Elizabeth, Eastern Cape, South Africa|
Monitoring of micro-organisms at all stages of production to ensure the manufacturing of sterile parenteral products in compliance with laid down standards
|Job Functions||Analysis,Chemistry, Physics and Biology,Compliance & Regulatory Affairs,Data Capturing,Laboratory Work,Quality Control|
|Industries||Fmcg (Fast Moving Consumer Goods Sector),Manufacturing,Pharmaceutical / Medical / Healthcare / Hygiene,Regulatory|
•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 FEFO
•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 bio load
•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. This includes the maintenance of a high level gowning qualification for entry into all graded areas.
•Assist in microbiological monitoring of media fills, environmental observations and identifications.
•Active participation of micro related projects which are aimed at reducing OOL results both in the laboratory and production areas
•Assist in the microbial testing of ETO samples, bio indicators and PRIONTEX garments
•Assist with theoretical and practical assessments of gowning competency qualifications of all FKMSA staff and active participation in the ongoing Aseptic Mentorship Program.
•Participation in the QMS and QRM systems and completion of related tasks which are consistent with the qualification and / or training of the incumbent
•From time to time carry out additional tasks within the laboratory that are consistent with the qualification and / or training of the incumbent
1.Ensuring compliance to currently guidelines and GMP practice.
B.Sc Microbiology and/ or Biotechnology or NTD/HNTD Microbiology
A minimum of one year’s experience within microbiology is required
|Job Closing Date||26/05/2020|
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