Senior Executive, QC Environment Monitoring

Key Responsibilities

• Perform routine Environmental Monitoring (EM) activities in classified cleanrooms (Grade A, B, C, D areas).

• Conduct viable and non-viable monitoring including- Active air sampling, Surface monitoring (contact plates/swabs), Personnel monitoring, Settling plate exposure studies, Particle monitoring support 

• Perform microbiological testing of Raw Materials, Water Systems (PW/WFI), In-process samples, and Finished Products as per validated methods.

• Handling sterility testing activities and ensure proper aseptic handling practices in microbiology laboratory.

• Perform microbial limit tests, endotoxin testing support (where applicable), and bioburden testing.

• 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.

• Support media fill (APS) activities from microbiological monitoring perspective.

• 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.

Eligibility

• M.Sc. (Microbiology / Biotechnology / Life Sciences) or equivalent qualification with Minimum 7–10 years of relevant experience in QC Microbiology.

Experience in sterile injectable manufacturing environment is mandatory/ preferred