Manager Microbiology
Abbott
Date: 2 days ago
City: Karachi
Contract type: Full time
Job Summary
Provide support to Manager Microbiology in QC activities of Microbiology Laboratories for both Landhi and Korangi Plants. To implement Quality GMP, GLP No Line Failure, Increase Productivity, Team Achievement, and other strategies aimed at achieving the Quality Control goals and supporting the business growth in Pakistan.
Principal Duties
Provide support to Manager Microbiology in QC activities of Microbiology Laboratories for both Landhi and Korangi Plants. To implement Quality GMP, GLP No Line Failure, Increase Productivity, Team Achievement, and other strategies aimed at achieving the Quality Control goals and supporting the business growth in Pakistan.
Principal Duties
- Ensure following activities of QC Microbiological Section:
- Timely availability of products
- Introduction of new products
- Implementation of CIP, QIP.
- Quality, cGMP, GLP and Data Integrity are compliant.
- To assist the manager in planning, organizing, lead & control of all activities fall in Micro. lab.
- To assist the manager in distribution of workload considering commitments, priorities, FIFO, absentees and lead time of finished product, Raw material, NVR and other job to be done. In case of not meeting lead-time despite of putting all efforts should immediately inform to Manager and ask for help and assistance.
- To perform all the Microbiological testing (as per authorized method) required for Raw Materials, Finished Products, Water and Environmental monitoring, Bioassays, Growth Promotion Test, Sterility, LAL, AMC, Preservative Efficacy test, Validation of Sterile & Non-Sterile Products, Equipment Qualification, Media fill run and challenge test of autoclave and dry heat sterilizer.
- To perform Micro lab Qualification/Periodic requalification activities against the LVMP.
- To perform Preparation of Documentation & Reviewed, SOP’s Preparation and provide support to Manager Microbiology in QC Activities.
- In case of any non-conformance the responsible person should immediately inform manager and must follow procedure for “Out of Specification”.
- Strictly follow All SOP’s used in Microbiological Section.
- To perform inventory of prepared media and culture as per frequency. No media (without tagging) should be found in area
- Standardization methods should be upgraded, and standardization record should be maintained properly.
- To perform all the Microbiological testing (as per the authorized methods) and as per the approved protocols for facility / utilities / environment / equipment’s and product validation by the validation section.
- Train and certify staff if planned by the manager.
- Regular record (Register etc.) checking for correctness and for meeting of other requirement for the purpose of re-training needs.
- In order to avoid any delay in testing, keep follow up with sampling group for in time sampling.
- Should write procedure to cover all activities for effective use and control in the area and to make sure that all group members follow these SOPs strictly. Authorized persons responsible for subsequent updating of SOPs in case of any change or improvement in area.
- Should keep best standard of Cleaning in Micro. Lab, washing area and autoclave room.
- Microbiologist is responsible to perform all the assignments or reports required as and when instructed by the Manager Microbiological section.
- To perform all validation activity related to utilities, finished products, raw material and Environmental monitoring of sterile and non-sterile area.
- Review/ write SOP's for Microbiological Section for effective control of all related activities, subsequent updating of these SOP's in case of change in practices and monitor compliance of all these SOP's.
- Any special project assigned by Q. A. Manager or Director Quality Assurance.
- Review self-performance against set Goals on Monthly basis with QAM and on yearly basis for his group.
- Support /Perform sampling of Glucose liquid as per Procedure KAR-QA-007-01-SOP.
- Knowledge of Documentation, in process control, Sampling of raw and finished product, technical
- problem resolution, and other all activities taking place in QC/QA.
- 8–10years of experience at similar type of position preferably in multinational Pharmaceutical.
- M.Sc. Microbiology.
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