Key Responsibilities /n /n

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

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- Ensure adherence to cGMP, GLP, and Data Integrity requirements.

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

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- Review microbiological test records, worksheets, and reports.

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

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

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

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

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

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- Conduct training and competency assessment of microbiology personnel.





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

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

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- Maintain laboratory housekeeping, safety, and regulatory compliance.

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

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- 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