Manage microbiology laboratory operations to ensure compliance with Containment Level II standards, GMP, company policies, and customer requirements.
Oversee microbial testing of raw materials, bulk, finished products, and purified water in accordance with established methods, ensuring proper documentation control.
Lead the environmental monitoring program (plant and microbiology lab), as well as sanitation and hygiene programs across the facility.
Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results, initiate CAPAs, and ensure timely implementation of corrective actions.
Prepare and approve quality incident reports, planned deviations, and change controls in compliance with regulatory requirements.
Maintain laboratory inventory and oversee equipmen...
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