Key Responsibilities - Ensure compliance with gowning/de-gowning procedures as per SOPs.

- Ensure adherence to cGMP, GLP, and Data Integrity requirements.
- Plan, allocate, and supervise daily activities of the Microbiology team.
- Review microbiological test records, worksheets, and reports.
- Ensure timely execution of routine microbiological testing and environmental monitoring.
- Execute and review qualification, validation, and method validation activities.
- Prepare and review SOPs, protocols, reports, and microbiology documentation.
- Coordinate with QA, Production, Engineering, and other departments for smooth laboratory operations.
- Lead investigations for OOS, OOT, deviations, contamination events, and ensure effective CAPA implementation.
- Conduct training and competency assessment of microbiology personnel.




- Ensure availability of media, reagents, consumables, and laboratory resources.
- Ensure calibration, qualification, and maintenance of microbiology laboratory equipment.
- Maintain laboratory housekeeping, safety, and regulatory compliance.
- Support and represent the department during internal, customer, and regulatory audits (USFDA and other global agencies).
- Drive continuous improvement and ensure overall compliance of microbiology laboratory operations.

Qualification: M.Sc. in Microbiology Experience: 12–15 years in a USFDA-approved OSD pharmaceutical manufacturing facility.

📌 Manager – Microbiology (OSD facility) (Baddi)
🏢 Acme Generics
📍 Baddi