Officer - Microbiology (Sterile)

B.Sc./ M.Sc. in Microbiology from a reputed university with a sound academic record.

Minimum 2 years of pharmaceutical industry experience, preferably in sterile manufacturing or pharmaceutical microbiology.

Good analytical, communication, and documentation skills.

Computer proficiency, including MS Office applications and professional email communication.

Perform microbiological testing of raw materials, finished products, pharmaceutical water, and environmental samples.

Conduct environmental monitoring of cleanrooms, including viable air monitoring, surface monitoring, and personnel monitoring, as applicable.

Perform sterility testing, bacterial endotoxin testing, bioburden testing, microbial limit testing, and growth promotion testing, according to approved procedures.

Support sterilization validation, aseptic process simulation (media fill), disinfectant efficacy studies, and other microbiological validation activities.

Monitor microbiological conditions in sterile manufacturing areas and support investigations into contamination events and monitor excursions.

Maintain culture media, reference microorganisms, reagents, and laboratory equipment in accordance with approved procedures.

Prepare and maintain microbiological test records, validation protocols, reports, and trend analyses.

Support GMP audits, regulatory inspections, deviation investigations, and CAPA implementation.

Ensure compliance with laboratory safety, biosafety, data integrity, and documentation requirements.