Manager, QC Environment Monitoring
Manager, QC Environment Monitoring
Amneal Pharmaceuticals- Posted 18 hours ago
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Job Description
Key Responsibilities
JOB DESCRIPTION
QUALIFICATIONS
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
More Info
Key Skills
Microbiological sampling
Viable settle plate and active air sampling programs
Air surface personnel monitoring
Viable and non-viable particle monitoring
Compressed gas and utility monitoring
Microbial trending data evaluation
About Company
Skills:
Incident Management, Root Cause Analysis, Stakeholder Management, EHS Management
Skills:
Technical Training, Quality Assurance, Training Need Analysis, Competency Gap Assessment, Blended Learning Methodologies, Skill Matrices, PAP PDF, Skill Development Strategies, Industry Certifications, Skill Mapping, Competency Frameworks, Livelihood Sustainability Plans, Apprenticeships, Vocational Training, Governance Frameworks
Skills:
Mobilization, skilling programs, Process Management, employer engagement, project management, counselling, Placement, Training, post-placement tracking
Skills:
audit processes, Quality Management Systems, risk-based approaches, injectable product quality standards, deviation management, aseptic manufacturing, regulatory inspections, Change control processes, CAPA systems, compliance requirements, cGMP regulations
Skills:
it risk management , Change Management, Release management, Servicenow, Vendor Management, System Management, Compliance Management, It Audit, Access Control