Manager, QC Environment Monitoring

Amneal India; Ahmedabad District; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Amneal India is seeking a senior Environmental Monitoring leader to oversee EM programs for sterile injectable and peptide manufacturing areas (Grade A, B, C, D cleanrooms) including isolator lines in Ahmedabad. The role requires deep microbiology knowledge and 15–18 years of QC Microbiology exposure.

You will design and execute EM strategies, ensure regulatory compliance (EU GMP Annex 1, USFDA aseptic guidance, WHO GMP), develop SOPs, lead CAPA, and collaborate with QA, Production, Engineering,

Qualifications

• M.Sc. in Microbiology/Biotechnology/Life Sciences with 15–18 years' experience in QC Microbiology and strong Environmental Monitoring exposure.
• Experience in sterile injectable manufacturing is mandatory/preferred.
• Strong GMP and regulatory knowledge and ability to lead EM strategy and investigations.

Responsibilities

• Lead and manage the EM program for cleanrooms (Grade A–D) including isolator lines.
• Oversee viable and non-viable particle, air, surface, and personnel monitoring activities.
• Ensure compliance with EU GMP Annex 1, US FDA aseptic guidance, WHO GMP, and CCS.
• Develop, review, and approve EM SOPs, protocols, and reports; lead CAPA investigations.
• Coordinate with QA, Production, Engineering, Validation, and QC to ensure contamination control.

Skills

Audit & Inspection Oversight

Cross-functional Collaboration

GMP & Regulatory Compliance Oversight

Quality Control & Compliance Assurance

Quality Risk Analysis & Control

Sterility Assurance

Technical Documentation

Education

M.Sc. in Microbiology / Biotechnology / Life Sciences

Tools

LIMS

Documentation Systems

Job description

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 strong Environmental Monitoring exposure

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

Required Skills

• Audit & Inspection Oversight
• Cross-functional Collaboration
• GMP & Regulatory Compliance Oversight
• Quality Control & Compliance Assurance
• Quality Risk Analysis & Control
• Sterility Assurance
• Technical Documentation

Job Info

• Locations Survey number 253,255,256,257, GJ, IN