Manager QC Environment Monitoring

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals LLC seeks an experienced Environmental Monitoring lead for sterile injectable and peptide manufacturing. You will manage EM programs across Grade A–D cleanrooms and isolator-based lines, ensuring strict regulatory alignment.

You will design EM strategies, oversee SOPs, data trending, CAPA, and cross-functional collaboration with QA, Production, Engineering, Validation, and QC to ensure aseptic manufacturing excellence.

Qualifications

• MSc in Microbiology/Biotechnology/Life Sciences with 15–18 years in QC Microbiology and EM exposure
• Experience in sterile injectable manufacturing environment is mandatory/preferred
• Strong knowledge of regulatory guidelines (EU GMP Annex 1, US FDA, WHO) and CCS

Responsibilities

• Lead EM program for sterile injectable and peptide manufacturing areas (Grade A–D cleanrooms) including isolator-based lines
• Design, review, and execute EM strategies: viable/non-viable monitoring, air/surface/personnel monitoring, gas and utility monitoring
• Develop and maintain EM SOPs, protocols, and reports; lead microbial trending and data evaluation
• Investigate EM excursions, perform root cause analysis, and implement CAPA
• Coordinate with QA, Production, Engineering, Validation, and QC for contamination control
• Ensure qualification and routine monitoring of cleanrooms, LAFs, biosafety cabinets, isolators, and HVAC systems
• Oversee microbiological sampling during routine production, media fills, and validation batches
• Ensure EM instruments are properly operated, calibrated, and maintained; maintain aseptic practices
• Support media fill simulations and 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 on aseptic behavior and contamination prevention to microbiology and production personnel

Skills

Environmental Monitoring

QC Microbiology

Sterile manufacturing

Regulatory compliance

Education

MSc in Microbiology/Biotech/Life Sciences

Tools

LIMS

ALCOA+

Job description

Job 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

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.

Requirements: