About the role
1. Testing & Analysis
- Perform microbiological testing of raw materials, in-process
samples, finished products, and water samples.
- Conduct microbial limit tests, sterility tests, endotoxin tests
(LAL), and identification of microorganisms.
- Carry out environmental monitoring of cleanrooms (settle plates,
air sampling, surface sampling, personnel monitoring).
- Monitor and test purified water, WFI, and compressed air systems.
2. Documentation & Compliance
- Maintain accurate and complete test records in compliance with GMP
and GDP requirements.
- Prepare and review Standard Operating Procedures (SOPs) related to
microbiological activities.
- Ensure all laboratory activities adhere to GLP (Good Laboratory
Practices).
3. Equipment Handling & Calibration
- Operate and maintain microbiology lab instruments such as
autoclaves, laminar airflows, incubators, microscopes, and particle
counters.
- Ensure timely calibration, qualification, and preventive
maintenance of microbiology equipment.
4. Validation & Qualification
- Participate in microbiological method validation and equipment
qualification activities.
- Conduct media growth promotion tests (GPT) and sterility
validations.
5. Compliance & Audit Support
- Assist during regulatory and customer audits by providing required
records and test data.
- Implement corrective and preventive actions (CAPA) for
non-conformances.