- Perform microbiological testing of finished medical devices, raw materials, water and process samples.
- Conduct sterility testing, bioburden testing and Bacterial Endotoxin Testing (BET) as per approved methods and standards.
- Perform environmental monitoring, including air, surface, settle plate and personnel monitoring.
- Prepare and sterilize media; perform growth promotion and media suitability testing.
- Maintain cultures, reference strains, media, reagents and microbiology laboratory records.
- Review and document test results, worksheets, logbooks and reports as per GDP and data-integrity requirements.
- Identify and report OOS/OOT, sterility failures, endotoxin failures and environmental monitoring excursions.
- Support investigations, root cause analysis, CAPA and validation/qualification activities related to microbiology.
- Ensure proper laboratory housekeeping, sanitization and compliance with approved SOPs.
- Coordinate with QA, Production, Engineering and other departments for microbiological and contamination-control requirements.
- Support internal/external audits and regulatory inspections by providing required microbiological records.
- Ensure compliance with applicable ISO 13485, ISO 11737, ISO 14644, pharmacopoeial and regulatory requirements.
- Perform other microbiological/QC activities assigned by the QC/QA Manager.
Pay: ₹25,000.00 - ₹35,000.00 per month
Advantages
- Health insurance
- Leave encashment
- Life insurance
- Provident Fund