Executive - Microbiology

**Title**:Executive - Microbiology**:

- Date: Apr 17, 2025
- Location: Dadra - Quality Control
- Company: Sun Pharmaceutical Industries Ltd

**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.**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.