Description

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.

Qualifications

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 workplace is mandatory/ preferred

📌 Senior Executive, QC Environment Monitoring (Ahmedabad)
🏢 Recognized
📍 Ahmedabad