Executive - Microbiology

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.