Manager, QC Environment Monitoring

Amneal; Gujarat; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Amneal in India seeks an Environmental Monitoring (EM) specialist to lead EM programs for sterile injectable production areas, including grade A/B/C/D cleanrooms and isolator lines.

You will design and implement EM strategies, oversee sampling, trend data, CAPA, change control, and maintain data integrity in LIMS, ensuring compliance with EU GMP Annex 1, USFDA aseptic guidance, WHO GMP, and CCS. Collaboration with QA/Production/Engineering is essential for continuous improvement.

Qualifications

• Thorough knowledge of microbiology and environmental monitoring concepts.
• Experience designing and reviewing EM strategies and programs.
• Familiarity with regulatory guidelines (EU GMP Annex 1, US FDA aseptic guidance, WHO GMP).
• Ability to lead investigations, root cause analysis, and CAPA.
• Experience with EM data generation, trending, and reporting in LIMS or similar systems.

Responsibilities

• Lead and manage the Environmental Monitoring program for sterile manufacturing areas (Grade A-D) including Isolator lines.
• Design, review, and execute EM strategies: viable/non-viable particle monitoring, air/surface/personnel monitoring, gas/utility monitoring, settle plates, active air sampling.
• Ensure compliance with regulatory guidelines and CCS; develop and approve EM SOPs, reports, and protocols.
• Lead microbial trending, data evaluation, CAPA for excursions, and change control involvement.
• Coordinate with QA, Production, Engineering, Validation, and QC to ensure contamination control and aseptic manufacturing.

Skills

Environmental Monitoring

Microbiology

Regulatory compliance

CAPA

LIMS

Tools

Active air samplers

Particle counters

Contact plates

LIMS

Job description

ROLE

• Design, review, and execute EM strategies including viable and non‑viable particle monitoring, air, surface, personnel monitoring, compressed gas and utility monitoring, and viable settle plate and active air sampling programs.
• Develop, review, and approve EM SOPs, protocols, and reports.
• Lead microbial trending, data

Full 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.

Job Type

Full Time

Amneal

Amneal Pharmaceuticals is a U.S.-based biopharmaceutical company. We are expanding access to safe, effective and affordable medicines.