Careers

Job Requirements

Key Responsiblities

1. Reports to the superiors on all matters pertaining to Microbiological quality control and laboratory activities.
2. To ensure planning, scheduling and supervising microbiology testing for starting material, packaging material, intermediate samples and finished products and ensure the testing performed in compliance with GMP, GLP and Good Aseptic Technique.
3. To oversee matters relating to work efficiency, personal safety, appraisal, discipline of Microbiology Laboratory staff and ensuring the performance during microbiological testing complies with specified SOPs.
4. To manage execution of conduction of microbiology Laboratory staff training with respect to GMP, GLP and technical operation for subjects related to microbiology.
5. To manage laboratory investigation upon encountering out of specification, issue the Out Of Specification report on time and assist superiors in implementing the corrective action for issued OOS.
6. To manage participation in providing technical support for R&D, QA and other relevant department pertaining to microbiological testing and validation.
7. To ensure Microbiological testing completed in time and is able to provide accurate and timely results on a constant basis in order to achieve department key performance.
8. Ensure the correct usage and in charge of maintenance of all Microbiology Laboratory instrument.
9. To manage purchasing, receiving and stock keeping of all material and media required in Microbiology Laboratory operations.
10. To manage stock reference cultures and ensure the correct usage storage condition of biological indicators.
11. To manage quality of work of subordinates.
12. To ensure test practices are of latest official monographs/ pharmacopoeia.
13. To manage the establishment and management of test protocols, SOP’s and product specifications for all finished products, intermediate products, starting materials and other testing required.
14. Responsible for overall performance of the subordinates in performance of their tasks.
15. Establish and review the microbiological test procedures, SOPs, and other related quality documents to ensure compliance with latest official monograph and regulatory requirement.
16. Ensure all laboratory equipment are well maintained, calibrated and in a good condition for testing.
17. Maintain personnel and clean room hygiene.
18. Conduct environmental monitoring and report if any out of specification (OOS).
19. To maintain the integrity and traceability of Microbiology Laboratory Clean Room and Production area environmental monitoring data by good record keeping, and to provide trending analysis on monthly basis.
20. To comply and work towards meeting the company’s quality policy, health safety and environment objectives and policies.
21. Any other job or assignment as assigned.
22. Ensure compliance to GMP, GLP, GSP, GDP and respective ISO guidelines.