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Jobs in Malaysia   »   Jobs in Johor Bahru   »   Quality Assurance / Control jobs   »   SENIOR ASSOCIATE QUALITY CONTROL MICROBIOLOGY

SENIOR ASSOCIATE QUALITY CONTROL MICROBIOLOGY

Johor Bahru

Job Responsibilities: 

  1. Ensure all type of water which is potable water, process water, purified water, water for injection and pure steam condensate being sampled from all required sampling points of water systems according to approved procedures.
  2. Ensure all the microbiological analysis such as Total Viable Aerobic Count, Test for Specified Microorganism and Bacterial Endotoxin Test is performed for water samples according to the approved procedures and the results is within the acceptance limit and recorded accordingly.
  3. Co-ordinate and ensure on the execution of environmental monitoring in the Production Drug Product and Production Drug Substance clean room areas, Quality Control Microbiology Laboratory and Inoculum Laboratory according to the schedule and approved procedures. Ensure the results are within the acceptance limit and recorded accordingly.
  4. Issuance and review or approve the test report for all analysis on water system samples and other plant utilities, analyse the results and prepare trending for the results obtained.
  5. Issuance and review or approve the test report for environmental monitoring activities in clean room areas, analyse the results and prepare trending for the results obtained.
  6. Manage and update on the documentation for Quality Control Microbiology department.
  7. Prepare and review for Standard Operating Procedure (SOP), Equipment Operating Procedure (EOP) and protocol according to current requirement and guidelines. Ensure on the implementation of the procedures.
  8. Prepare and review for Standard Testing Procedures (STP) and Specifications for Finished Product (FP), Raw Material (RM), Packaging Material (PM), In-Process (IP) and stability study according to current requirement and guidelines. Ensure on the implementation of the procedures.
  9. Ensure all the microbiological isolates is been identified using the biochemical test or rapid biochemical test system.
  10. Perform investigation for laboratory Out Of Specification (OOS), non-conformance and deviation. Ensure on the implementation of CAPA.
  11. Initiate and review of Change Management relate to Quality Control Microbiology department.
  12. Coordinate with other departments to support in the validation or studies involving microbiological activities and compilation of the reports.
  13. Co-ordinate for Gowning Qualification.
  14. Involve in the Media Fill for Drug Product and ensure on the execution according to microbiological parameter requirement.
  15. Perform risk assessments based on the requirements.
  16. Perform self-inspections and ensure on the implementation of the corrective action and improvement plans.
  17. Conduct training on the procedures related to general microbiological procedures, equipment, sampling or analysis and maintain the employee personnel record according to Good Documentation Practice (GDP).
  18. Maintain the equipment in Quality Control Microbiology Laboratory and ensure the calibration or verification or qualification is performed accordingly.
  19. Ensure all the inventory stock of consumable, disinfectant, reagents and media for sampling and analysis based on the requirement.
  20. Review record for all equipment, reagent, media, glass wares and consumables used in the Quality Control Microbiology Laboratory.
  21. Ensure the testing area in Quality Control Microbiology Laboratory is monitored for Temperature, Relative Humidity (RH) and Differential Pressure and all the parameter are within the limit.
  22. Maintain the cleanliness of Quality Control Microbiology Laboratory according to Good Microbiology Practice; ensure the cleaning and disinfection activities are performed according to the schedule.
  23. Ensure all glass ware used for any related activities are sterilized or depyrogenated using the qualified and calibrated equipment according to the approved procedures.
  24. Support and involve in all cGMP activities organized by Quality Assurance which relate to Quality Control Microbiology department.
  25. Ensure all the related activities perform in Quality Control Microbiology Laboratory strictly adhere to laboratory policy, Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and laboratory safety guidelines.
  26. Perform any other duties assigned by the immediate superior or HOD.

Job Requirements:

  • Assist and ensure all required routine and non-routine microbiological testing is performed for Finished Product (FP), Raw Material (RM), Packaging Material (PM), In-Process (IP) and stability study samples according to approved procedures and the results is within the acceptance criteria.
  • Ensure on the media sterilization, qualification and QC check is performed according to approved procedures and meet the acceptance criteria.
  • Assist for the equipment qualification in Quality Control Microbiology Laboratory whenever required.
  • Issuance, review or approve test report for any other microbiological analysis.
  • Ensure the microbiological wastes are decontaminated and disposed according to approved procedures.
  • Assist the reporting manager during his absence.
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Company Overview

Biocon, India’s leading and Asia’s premier biopharmaceutical enterprise has set up its first state-of-art overseas bio-pharma manufacturing and research facility located within a 40 acre compound, at Bio-XCell, Johor in Malaysia. With an investment of over USD 200 million, this is the largest foreign investment in the Biopharma sector in Malaysia. The facility once fully operational in 2016, will be the largest integrated insulin production plant in Asia. Biocon’s Malaysia facility will further augment its capabilities to cater to the global needs of diabetic patients for affordable insulin and insulin analogs. Biocon Malaysia offers an excellent career opportunity for biotech professionals.

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Company Summary
Biocon Sdn Bhd
http://www.biocon.com
501-1000 employees
BioTechnology / Pharmaceutical