Responsibilities:
- Perform routine microbiological testing of raw materials, in-process samples, and finished products.
- Conduct environmental monitoring and water testing.
- Identify and analyze microbial contamination and recommend corrective actions.
- Maintain accurate documentation and lab records as per regulatory requirements.
- Ensure compliance with GMP, GLP, and safety standards.
- Prepare media, reagents, and cultures for testing.
- Calibrate and maintain laboratory instruments.
- Support audits and inspections (internal and external).
- Investigate deviations, OOS (Out of Specification), and implement CAPA.
- Collaborate with QA and production teams for quality assurance.
Required Skills
- Experience with environmental monitoring and sterility testing.
- Familiarity with GMP, GLP, and regulatory guidelines.
- Positive documentation and reporting skills.
- Attention to detail and analytical thinking.