08 Sep
|
TalentXplore
|
Una
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 (Positive 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.
📌 QC - Micro Executive (Una)
🏢 TalentXplore
📍 Una