QC Microbiology Executive JD

Key Responsibilities

1. Aseptic Testing & Analysis

- Perform and review Sterility Testing of finished injectable batches using direct inoculation or membrane filtration methods.
- Conduct Bacterial Endotoxin Testing (BET) (LAL test) for raw materials, in-process samples, and finished products.
- Perform Bioburden Testing and Microbial Limit Testing (MLT).

2. Environmental & Utility Monitoring

- Conduct Environmental Monitoring (EM) in aseptic core areas (Grade A/B), including active/passive air sampling, surface swabbing, and personnel monitoring.
- Sample and analyze Water for Injection (WFI) and Purified Water systems daily/weekly for bioburden and endotoxins.
- Perform particulate matter analysis where applicable.

3. Lab Operations & Culture Handling

- Prepare and sterilize culture media, buffers, and reagents.
- Perform Growth Promotion Testing (GPT)



on all prepared media batches.
- Maintain and preserve standard microbial cultures (e.g., ATCC/MTCC strains).
- Calibrate and operate laboratory equipment (e.g., autoclaves, incubators, pH meters).

4. Quality Management System (QMS) & Compliance

- Investigate Out of Specification (OOS), Out of Trend (OOT), and microbiological deviations.
- Draft and execute Corrective and Preventive Actions (CAPA).
- Review and update Standard Operating Procedures (SOPs) and maintain ALCOA+ documentation.
- Support internal audits and regulatory inspections (USFDA, MHRA, WHO-GMP).

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📌 Executive Qc Microbiologist (Hyderabad)
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📍 Hyderabad