Key Responsibilities
- Perform microbiological testing of raw materials, finished products, purified water, and environmental monitoring samples.
- Conduct environmental monitoring of manufacturing areas (air, surface, personnel, and water).
- Prepare culture media and maintain microbial cultures as per SOPs.
- Perform microbial limit tests, sterility tests, and endotoxin testing (as applicable).
- Ensure proper documentation in accordance with GMP, GLP, and data integrity requirements.
- Maintain microbiology laboratory instruments and ensure timely calibration.
- Investigate OOS/OOT results and assist in CAPA implementation.
- Follow laboratory safety practices and company SOPs.
- Support internal, customer, and regulatory audits.
Required Skills
- Knowledge of GMP, GLP,
and microbiology laboratory practices.
- Experience in Environmental Monitoring (EM).
- Positive documentation skills.
- Familiarity with SOPs, STPs, and microbiological testing procedures.
- Strong analytical and problem-solving skills.
- Ability to work independently and as part of a team.