Senior Manager Microbiology (Sterile facility)

Key Responsibilities

1. Ensure compliance with gowning/de-gowning procedures as per SOPs.
2. Ensure adherence to cGMP, GLP, and Data Integrity requirements.
3. Plan, allocate, and supervise daily activities of the Microbiology team.
4. Review microbiological test records, worksheets, and reports.
5. Ensure timely execution of routine microbiological testing and environmental monitoring.
6. Execute and review qualification, validation, and method validation activities.
7. Prepare and review SOPs, protocols, reports, and microbiology documentation.
8. Coordinate with QA, Production, Engineering, and other departments for smooth laboratory operations.
9. Lead investigations for OOS, OOT, deviations, contamination events, and ensure effective CAPA implementation.
10. Conduct training and competency assessment of microbiology personnel.
11. Ensure availability of media, reagents, consumables, and laboratory resources.
12. Ensure calibration, qualification, and maintenance of microbiology laboratory equipment.
13. Maintain laboratory housekeeping, safety, and regulatory compliance.
14. Support and represent the department during internal, customer, and regulatory audits (USFDA and other global agencies).
15. Drive continuous improvement and ensure overall compliance of microbiology laboratory operations.

Preferred candidate profile