Chief Quality Assurance Specialist

2 weeks ago

Pune, Maharashtra, India beBeeMicrobiologist Full time US$ 6,00,000 - US$ 12,00,000
Job Description:

As a microbiologist, you will be responsible for ensuring the quality and safety of products in a pharmaceutical or biotechnology environment. This involves conducting environmental monitoring, sampling and testing of purified water and raw water, as well as performing microbial limit tests and sterility testing.

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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.
  • 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).
  • 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).
  • 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.
Required Skills and Qualifications:

A M.Sc/B.Sc. degree in Microbiology, Biotechnology or any Life sciences domain is required. At least 2-4 years experience in a similar role is also necessary.

Benefits:

This position offers a full-time, permanent role with opportunities for career growth and development.

Others:

Location: Tumkur Factory

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