Mircobiologist Supervisor at Fresenius Group

• Ensuring compliance to currently guidelines and GMP practice.
• Assist in external Audit as SME’s for respective departmental sections.
• SOP writing, training and protocols development and execution and report writing.
• Approval for release of all microbiology related test results.
• Logbook review and signing to ensure compliance with GRK.
• Ensuring timeous testing and release of Microbial Analysis.
• Oversee maintenance of cultures, medical & standards in the MicroLab (QC control & GPT).
• Execute & participation on Events, Change controls, CAPA etc.
• Completion of OOS/OOT investigation and Hypothesis testing when required
• Basic Purchasing/ordering (As required for Lab use).
• Ensuring correct use, maintenance and calibration of laboratory equipment et Pipette, pH meters.
• Method Validation of products and raw materials.
• Qualification of Analysts/Instruments/Cleanrooms/Personnel when required.
• Activate participation of Micro related projects which are aimed at reducing OOS results both in the laboratory and production.
• Staff management and related administrative duties.
• Completion of batch release queries for product release purposed.
• Training of new staff in accordance to the Job specific function.
• Compliance with the Self-Inspection when required
• From time to time, carry out other jobs within the factory /department, consistent with the grade qualification and training of the incumbent.

Requirements

• A minimum of 3 years’ experience + Supervisor
• Experience in the pharmaceutical industry will be advantageous
• Computer literacy (MS Office, Visio, Syspro,)