Job description
- 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.
- 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).
- 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.
- Validation & Qualification Participate in microbiological method validation and equipment qualification activities. Conduct media growth promotion tests (GPT) and sterility validations.
- 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.