ROLE
– Handling sterility testing activities and ensure proper aseptic handling practices in microbiology laboratory.
– Prepare and review EM and microbiology test records, worksheets, and logbooks in compliance with GMP.
– Perform the investigation of EM excursions & Microbiology testing, OOS, OOT, and deviations, and support root cause analysis.
– Ensure proper incubation, observation, and interpretation of microbiological test samples.
– Maintain microbiology laboratory hygiene, aseptic practices, and contamination control standards.
– Ensure calibration, cleaning, and maintenance of microbiology instruments and EM equipment.
– Involve in change control review and approval, Deviation, Investigation and root cause investigation.
– Involve in SOP Review and its implementation and Training.
– Maintain compliance with ALCOA+ data integrity principles in manual and electronic documentation systems.
– Ensure timely completion of testing activities to support production and product release timelines.
– Assist in preparation and revision of SOPs, protocols, and microbiology-related documentation.
– Coordinate with QA, Production, Validation, and Engineering teams for microbiological compliance activities.
– Participate in regulatory and customer audits by providing required microbiological data and records.
– Support implementation of contamination control practices in sterile manufacturing areas.

REQUIREMENTS
– No requirements listed

BENEFITS
– No benefits listed