Job DescriptionKey Responsibilities
N
- n
- Ensure compliancewith gowning/de-gowning procedures as per SOPs. N
- Ensure adherence to cGMP, 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 executionof 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 forOOS, 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

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

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