
Senior Laboratory Scientist
2 weeks ago
As a Microbiologist, you will be responsible for ensuring the quality and safety of products by conducting environmental monitoring, sampling, and testing, and performing various microbiological tests.
Key Responsibilities:- Perform 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, APIs and KSMs.
- 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).
- Prepare and review Standard Operating Procedures (SOPs), protocols, and reports.
- 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.
- Participate in out-of-specification (OOS) or out-of-trend (OOT) investigations related to microbial results.
- Perform root cause analysis and propose corrective and preventive actions (CAPA).
- Conduct microbiological risk assessments of processes and systems.
- Maintain microbial culture collection and reference strains.
- Ensure calibration and qualification of lab instruments (incubators, autoclaves, laminar airflows, microscopes).
- 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.
- Knowledge of microbiology and laboratory techniques.
- Familiarity with Good Manufacturing Practice (GMP) regulations and standards.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
Please submit your application, including your resume and cover letter, to us. We look forward to hearing from you.
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