Scientist - Quality Assurance & Control

5 days ago

Amrāvati, Maharashtra, India beBeeMicrobiologist Full time ₹ 8,00,000 - ₹ 12,00,000

We are seeking a skilled and detail-oriented microbiologist to join our team in this dynamic role.

This position is responsible for ensuring the quality and safety of our products by performing environmental monitoring, sampling, and testing.

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.
  • To 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).
  • To 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.

Requirements:

  • Bachelor's or Master's degree in Microbiology, Biotechnology, or a related field.
  • Minimum 2 years of experience in API/pharmaceutical industry.
  • Strong knowledge of microbiological techniques and principles.
  • Ability to work independently and collaboratively as part of a team.
  • Excellent communication and problem-solving skills.

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