Microbiologist

Designation: Microbiologist

Qualification: M.Sc/B.Sc. in Microbiology, Biotechnology or any Life sciences domain.

Desired Experience: 2 to 4 years experience in API/Pharmaceutical industry

Employee Type: Full Time, Permanent

Location: Tumkur Factory

Job Responsibilities:

Responsibilities in Details

· 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, 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).

· 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.