Experience: Minimum 2+ Years (Strictly in Medical Devices / Pharmaceuticals)

Key Roles & Responsibilities

- Cleanroom & Environmental Monitoring: Perform routine microbiological monitoring of manufacturing areas (Class 10,000 / Class 100,000) using air sampling, settle plates, finger dabs, and surface swab methods.
- Sterility & Bioburden Testing: Conduct routine bioburden testing of components before sterilization and sterility testing of finished medical devices (IV Cannulas, Catheters, etc.).
- Bacterial Endotoxin Test (BET): Perform Gel-Clot / Kinetic LAL testing for bacterial endotoxins on product surfaces and fluid pathways to ensure pyrogen-free devices.
- Water System Analysis: Conduct regular microbiological sampling and testing (Total Viable Count) of Purified Water and Water for Injection (WFI) systems.
- Media & Culture Management: Oversee culture media preparation, sterilization,



Growth Promotion Testing (GPT), and maintain reference cultures safely.
- Equipment Validation: Assist in the qualification and validation of laboratory equipment like Autoclaves, Incubators, and Laminar Air Flow (LAF) benches.
- Documentation & Audit Compliance: Maintain flawless, real-time documentation, logbooks, and test reports in compliance with ISO 13485, CE certification, and Indian GMP guidelines.
- OOS & CAPA Management: Investigate Out-of-Specification (OOS) results or microbial contamination spikes, perform root cause analysis, and implement Corrective and Preventive Actions (CAPA).

Pay: ₹28,000.00 - ₹35,000.00 per month

Work Location: In person

📌 QC Microbiologist (India)
🏢 Krishna Chemicals
📍 India