Job Description

Key Responsibilities

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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.
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Qualification: M.Sc. in Microbiology

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

📌 Manager Microbiology Osd Facility Baddi (India)
🏢 Acme Generics
📍 India