Senior Microbiologist

Job Requirements:

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

Key Responsibilities:

1. 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.
2. 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.
3. To manage execution of conduction of microbiology Laboratory staff training with respect to GMP, GLP and technical operation for subjects related to microbiology.
4. 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.
5. To manage participation in providing technical support for R&D, QA and other relevant department pertaining to microbiological testing and validation.
6. 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.
7. To ensure test practices are of latest official monographs/pharmacopoeia.
8. Establish and review the microbiological test procedures, SOPs, and other related quality documents to ensure compliance with latest official monograph and regulatory requirement.
9. Conduct environmental monitoring and report if any out of specification (OOS).
10. 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.
11. Ensure compliance to GMP, GLP, GSP, GDP and respective ISO guidelines.