Senior Manager, Quality Control

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 1,400,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad is seeking a professional to lead and manage the Environmental Monitoring (EM) program for sterile injectable manufacturing areas. The role requires in-depth knowledge of microbiology and significant experience in QC Microbiology.

The ideal candidate should have at least 15–18 years of relevant experience and strong exposure to Environmental Monitoring in a sterile injectable manufacturing environment. Responsibilities include compliance assurance, data integrity, and collaboration across teams.

Qualifications

• 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.

Responsibilities

• Lead and manage the Environmental Monitoring (EM) program for sterile injectable manufacturing areas.
• Design, review, and execute EM strategies.
• Ensure compliance with regulatory guidelines.
• Investigate EM excursions and implement CAPA.
• Oversee microbiological sampling activities during routine production.

Skills

Cross‑functional Collaboration

OOS Results Review & Analysis

Quality & Audit Preparedness

Quality Control & Compliance Assurance

Quality Risk Analysis & Control

Regulatory Compliance

Stakeholder Management

Strategic Planning & Implementation

Validation & Qualification Oversight

Education

M.Sc. in Microbiology / Biotechnology / Life Sciences

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

• Cross‑functional Collaboration
• OOS Results Review & Analysis
• Quality & Audit Preparedness
• Quality Control & Compliance Assurance
• Quality Risk Analysis & Control
• Regulatory Compliance
• Stakeholder Management
• Strategic Planning & Implementation
• Validation & Qualification Oversight