Core Responsibilities
- Environmental Monitoring: Conduct routine air sampling, surface swabbing, and personnel monitoring in cleanrooms and controlled manufacturing zones.
- Water System Testing: Perform bioburden, conductivity, and TOC analysis on Purified Water (PW) and Water for Injection (WFI) systems.
- Microbiological Analysis: Execute Microbial Limit Tests (MLT), Bacterial Endotoxin Tests (BET), and sterility testing on raw materials, intermediates, and final APIs.
- Media Management: Prepare, autoclave, and validate culture media while conducting rigorous Growth Promotion Testing (GPT).
- Equipment Management: Operate, calibrate, and qualify critical microbiology lab equipment including autoclaves, incubators, and laminar air flow benches.
- Documentation & Compliance: Maintain real-time, accurate laboratory logbooks and records in strict compliance with ALCOA+ data integrity principles and cGMP/GLP standards.
- Investigations: Support investigations into Out of Specification (OOS) results, Out of Trend (OOT) data, and environmental monitoring deviations.
- CAPA Execution: Assist in root cause analysis and execute assigned Corrective and Preventive Actions (CAPA) to prevent contamination.
Pay: ₹250,000.00 - ₹350,000.00 per year
Benefits:
- Leave encashment
- Paid sick time
- Provident Fund
Application Question(s):
- where is your current location ?
- what is your total experience ?
- do you have experience in API ?
- What your current CTC ?
- What your expected CTC ?
- If selected, how soon you can join
Location:
- Vapi, Gujarat (Vapi) (Preferred)
Work Location: In person
