Job Description

Job Purpose:
To oversee and manage microbiological activities ensuring compliance with cGMP, GLP, regulatory standards, and company policies in the Oral Solid Dosage (OSD) manufacturing environment.
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Key Responsibilities:

• Conduct and supervise microbiological testing of raw materials, finished products, in-process samples, and water systems (Purified Water, WFI).
• Monitor and trend environmental conditions in production areas (EM: viable & non-viable monitoring).
• Handle and review activities related to microbial limit testing, pathogen testing, and sterility testing (if applicable).
• Perform and review validation activities like media fill, cleanroom qualification, water system validation, and disinfectant efficacy studies.
• Ensure timely calibration and validation of microbiological instruments (e.g., Laminar Air Flow, Incubators, Particle Counters).
• Support investigations for OOS/OOT and deviations, and assist in CAPA implementation.
• Ensure adherence to SOPs, data integrity, and documentation practices.
• Train and mentor junior microbiologists in techniques and GMP practices.
• Coordinate with production, QA, and regulatory teams for audits and inspections.
• Stay updated on regulatory guidelines (e.g., USFDA, MHRA, WHO, EU-GMP) related to microbiology and cleanroom controls.