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GMP Compliance & Testing
- Adhere to current Good Manufacturing Practices (cGMP) in all activities.
- Perform microbial limit tests for finished products, raw materials, compressed air, surfaces, and air in production areas and sampling rooms.
- Conduct Personal Hygiene tests for employees and microbial testing for water systems.
- Instrument Monitoring & Calibration:
- Monitor the temperature and performance of lab instruments, including calibration as per SOPs.
- Perform media preparation, sterilization, and quality control of lab instruments.
Sample Testing & Documentation
- Analyze samples using approved methods, maintain traceability by recording all activities in logbooks, and report test results in a timely manner using approved forms.
- Investigate and document OOS (Out of Specification) results and participate in CAPA processes.
- Housekeeping & Waste Management:
- Ensure neatness in the lab, manage waste disposal according to SOPs, and perform decontamination of biohazardous waste.
- Additional Responsibilities:
- Assist in preparing and reviewing SOPs, specifications, protocols, and trending reports.
- Participate in environmental monitoring, EMPQ, and risk assessment studies.
- Follow up on instrument calibration programs and ensure compliance with Good Laboratory Practices.
