Careers

Job Requirements

• Minimum 5 years experience in leading micro section and sound knowledge of microbiology development
• Degree or Master in Microbiology
• Knowledge in development of microbiology procedure and method
• Knowledge of sterile and non-sterile doses forms

Key Responsiblities

1. To plan, 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.
2. Assist superiors for matters relating to work efficiency, personal safety, appraisal, discipline of Microbiology Laboratory staff and ensuring the performance during microbiological testing complies with specified SOPs, GMP, GLP and Good Aseptic Technique.
3. Conduct Microbiology Laboratory staff training with respect to GMP, GLP and technical operation for subjects related to microbiology.
4. To assist superiors and participate in providing technical support for R&D, QA and other relevant department pertaining to microbiological testing and validation.
5. To ensure Microbiological testing completed in time and be able to provide accurate and timely results on a constant basis in order to achieve department key performance.
6. Ensure the correct usage and in charge of maintenance of all Microbiology Laboratory instrument.
7. To do purchasing, receiving and stock keeping of all material and media required in Microbiology Laboratory operations.
8. To monitor the stock reference cultures and ensure the correct usage of biological indicators.
9. To monitor, supervise and ensure the availability of the good quality of media prepared in Microbiology Laboratory at all time for in house and production usage.
10. Responsible in scheduling, conducting and monitoring the bio-burden of critical system, pharmaceutical system and production area as and when required, and ensure complies to the specification.
11. To report and conduct 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.
12. Establish and review the microbiological test procedures, SOPs, and other related quality documents to ensure compliance with latest official monograph and regulatory requirement.
13. Ensure all laboratory equipment are well maintained and in a good condition for testing.
14. 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.
15. To comply and work towards meeting the company’s quality policy, health safety and environment objectives and policies.
16. Responsible to participate in any activities pertaining to training, safety, first-aid and fire-fighting organized by the company for the benefits of staff and company.