Manager - Microbiology (OSD facility)

Acme Generics · Himachal Pradesh, India

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.