Description

Key Responsibilities

- Lead and manage the Environmental Monitoring (EM) program for sterile injectable and peptide manufacturing areas (Grade A, B, C, D cleanrooms) including Isolator based lines.

- Individual should have thorough knowledge of microbiology as well.

- Design, review, and execute EM strategies including:

- Viable and non-viable particle monitoring

- Air, surface, personnel monitoring

- Compressed gas and utility monitoring

- Viable settle plate and active air sampling programs

- Ensure compliance with regulatory guidelines including EU GMP Annex 1, USFDA aseptic guidance, WHO GMP, and internal CCS (Contamination Control Strategy).

- Develop, review, and approve EM SOPs, protocols, and reports.

- Lead microbial trending, data evaluation, and periodic review of environmental monitoring results.

- Investigate EM excursions, contamination events, and atypical results; perform root cause analysis and implement CAPA.

- Involve in change control review and approval, Deviation, Investigation and root cause investigation.

- Involve in SOP Review and its implementation and Training.

- Coordinate with QA, Production, Engineering, Validation, and QC teams for contamination control and sterile manufacturing assurance.

- Ensure qualification and routine monitoring of cleanrooms, LAFs, biosafety cabinets, isolators,



and HVAC systems from microbiological perspective.

- Oversee microbiological sampling activities during routine production, media fills, and validation batches.

- Ensure proper operation, calibration, and maintenance of EM instruments (active air samplers, particle counters, contact plates, etc.).

- Maintain aseptic practices and hygiene compliance within controlled manufacturing environments.

- Support media fill simulations and aseptic process simulations (APS) with microbiological oversight.

- Ensure data integrity compliance (ALCOA+) in EM data recording and reporting systems (LIMS and manual records).

- Participate in regulatory inspections and client audits by presenting EM strategy, data, and investigations.

- Drive continuous improvement in contamination control practices and EM program effectiveness.

- Provide training to microbiology and production personnel on aseptic behavior and contamination prevention practices.

Qualifications

- M.Sc. (Microbiology / Biotechnology / Life Sciences) or equivalent qualification with Minimum 15–18 years of relevant experience in QC Microbiology with solid Environmental Monitoring exposure

- Strong Experience in sterile injectable manufacturing environment is mandatory/ preferred.

📌 Senior Manager, Quality Control (Ahmedabad)
🏢 Important Company of the Sector
📍 Ahmedabad