Key Responsibilities

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

n Ensure adherence to c GMP, GLP, and Data Integrity requirements.

n Plan, allocate, and supervise daily activities of the Microbiology team.

n Review microbiological test records, worksheets, and reports.

n Ensure timely execution of routine microbiological testing and environmental monitoring.

n Execute and review qualification, validation, and method validation activities.

n Prepare and review SOPs, protocols, reports, and microbiology documentation.

n Coordinate with QA, Production, Engineering, and other departments for smooth laboratory operations.

n Lead investigations for OOS, OOT, deviations, contamination events, and ensure effective CAPA implementation.

n Conduct training and competency assessment of microbiology personnel.





n Ensure availability of media, reagents, consumables, and laboratory resources.

n Ensure calibration, qualification, and maintenance of microbiology laboratory equipment.

n Maintain laboratory housekeeping, safety, and regulatory compliance.

n Support and represent the department during internal, customer, and regulatory audits (USFDA and other global agencies).

n Drive continuous improvement and ensure overall compliance of microbiology laboratory operations.

n n

n Qualification: M. Sc. in Microbiology

n

n Experience: 12–15 years in a USFDA-approved OSD pharmaceutical manufacturing facility .

n

📌 Manager - Microbiology (osd Facility) (Baddi)
🏢 Acme Generics
📍 Baddi