Senior Officer - QC (Micro)

Role & responsibilities

1. Microbiological Analysis
- Conduct microbial limit test, sterility test, endotoxin testing, and bioburden analysis on raw materials, in-process, and finished products. - Perform water testing for purified water and potable water systems as per pharmacopeial standards. - Conduct environmental monitoring of cleanrooms and controlled areas, including settle plates, active air sampling, and surface monitoring.

2. Documentation & Compliance
- Prepare and review analytical reports, logbooks, and records in line with GDP (Good Documentation Practices). - Ensure compliance with GMP, WHO, USFDA, MHRA, and other regulatory guidelines. - Handle SOP preparation, revision, and adherence for microbiology operations.

3. Equipment Handling & Calibration
- Operate and maintain autoclaves, LAF, incubators, BOD chambers, particle counters, and microbiological instruments. - Ensure timely calibration and qualification of instruments.

4. Quality & Investigation
- Support OOS (Out of Specification), OOT (Out of Trend), and deviation investigations related to microbiological testing. - Assist in CAPA implementation for microbiology-related observations.

5. Training & Safety
- Provide training to junior team members on microbiology practices and SOPs. - Follow and enforce safety guidelines for handling microbial cultures and hazardous materials.

Key Skills & Competencies:

- Strong knowledge of pharmacopeial methods (IP, BP, USP, EP) and cGMP guidelines.
- Hands-on experience with microbial testing techniques and environmental monitoring. - Good understanding of sterile and non-sterile product testing requirements. - Analytical mindset, attention to detail, and good documentation skills. - Ability to work in team environment and handle regulatory audits confidently.