Manager, QC Environment Monitoring

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.

Eligibility:

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

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