
Leading Scientist: A Microbial Expert
4 days ago
Job Title: Microbiologist
About the Role:
We are seeking a highly motivated and detail-oriented professional to work as a microbiologist, ensuring the quality and safety of our products.
Key Responsibilities:
- Conduct environmental monitoring in classified areas to maintain aseptic conditions.
- Sample and test purified water and raw water for microbial contamination.
- Perform Microbial Limit tests, BET, Sterility testing, etc. of water, APIs, and KSMs.
- Support cleaning validation by analyzing swab/rinse microbiological samples.
- Conduct microbiological validation studies (e.g., filter integrity testing, media fills for aseptic processes).
- Participate in qualifying controlled areas, equipment, and utilities (HVAC, water systems, compressed air).
- Prepare and review Standard Operating Procedures (SOPs), protocols, and reports.
- Maintain accurate microbiological records in accordance with GMP and data integrity requirements (ALCOA+ principles).
- Assist in 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.
- Analyze root causes and propose corrective and preventive actions (CAPA).
- Conduct microbiological risk assessments of processes and systems.
- Manage microbial culture collections and reference strains.
- Certify laboratory instruments (incubators, autoclaves, laminar airflows, microscopes).
- Handle, dispose of, and follow biosafety practices for microbial cultures.
- Train production and quality staff on microbiological hygiene and aseptic practices.
- Enhance contamination control strategies through continuous improvement.
- Stay updated with pharmacopeia changes, ICH guidelines, and regulatory expectations.
Requirements:
- Bachelor's/Master's degree in Microbiology, Biotechnology, or Life Sciences.
- 2-4 years' experience in the API/Pharmaceutical industry.
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