Job Description
Key Job Responsibilities
- Microbiological Testing: Perform bioburden, sterility, and endotoxin tests on raw materials, in-process products, and finished goods.
- Environmental Monitoring (EM): Conduct environmental monitoring of cleanrooms (particle monitoring, viable air sampling, surface monitoring) and utility systems (water, compressed air).
- Quality Control & Compliance: Adhere to Good Manufacturing Practices (GMP) and SOPs to ensure safety and compliance with international standards.
- Investigations: Support Investigations for Microbiology Out-of-Specification (OOS) results, deviations, and sterility assurance failures.
- Lab Maintenance: Maintain laboratory equipment, prepare media, conduct growth promotion tests, and manage microbial identification of isolates.
- Documentation: Review and update standard operating procedures (SOPs) and ensure all test data is accurately documented.
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