
Life Sciences Professional
2 days ago
Career Overview:
A Microbiologist is a professional responsible for ensuring the quality and safety of products by controlling microbial contamination.
Key Responsibilities:
- Conduct environmental monitoring of classified areas (air, surfaces, and personnel) to ensure aseptic conditions.
- Sampling and testing of purified water and raw water.
- Perform Microbial Limit tests, BET, Sterility testing etc of water, API's and KSM's
- Support for cleaning validation by performing swab/rinse microbiological analysis.
- Conduct microbiological validation studies (e.g., filter integrity testing, media fills for aseptic processes).
- Participate in qualification of controlled areas, equipment, and utilities (HVAC, water systems, compressed air).
- Professional Expertise:
- Maintain accurate microbiological records as per GMP and data integrity requirements (ALCOA+ principles).
- Support regulatory inspections and customer audits and respond to microbiology-related queries.
- Investigate out-of-specification (OOS) or out-of-trend (OOT) results related to microbial findings.
- Propose corrective and preventive actions (CAPA) following root cause analysis.
- Conduct microbiological risk assessments of processes and systems.
- Maintain microbial culture collection and reference strains.
- Ensure proper handling, disposal, and biosafety practices for microbial cultures.
- Train production and quality staff on microbiological hygiene and aseptic practices.
- Contribute to continuous improvement of contamination control strategies.
- Stay updated with pharmacopeia changes, ICH guidelines, and regulatory expectations.
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