- Perform microbial limit testing (MLT), bioburden testing, and endotoxin/LAL testing on raw materials, in-process samples, and finished productsConduct water system testing (purified water, WFI) in accordance with USP/EP/IP pharmacopoeial standards
- Carry out environmental monitoring (EM) of cleanrooms, manufacturing areas, and classified zonesPerform identification of microbial isolates using biochemical and automated systems (e.g., VITEK, MALDI-TOF
- Ensure all microbiology activities comply with GMP, GLP, cGMP.
- Author, review, and update Standard Operating Procedures (SOPs), test methods, and validation protocols
- Support method validation and verification activities for microbiological test methods
- Raise and investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results with thorough root cause analysis
- Manage laboratory deviations, CAPAs, and change controls in a
Job Type: Full-time
Pay: ₹20,000.00 - ₹45,000.00 per month
Benefits:
Experience:
- total work: 3 years (Preferred)
Work Location: In person
