– AGM Quality Control (QC Head)

Designation: Assistant General Manager (AGM) – Quality Control

Department: Quality Control

Industry: Pharmaceutical Manufacturing (OSD Preferred, Sterile Exposure Desirable )

Reporting To: Site Quality Head

Job Purpose To lead the Quality Control function and ensure compliance with cGMP requirements, regulatory standards, and quality systems. The role will be responsible for managing chemical, instrumental & stability testing activities, ensuring timely product release, regulatory compliance, and laboratory excellence. Candidate should have strong experience in Oral Solid Dosage (OSD) manufacturing and exposure to Sterile/Injectable operations will be preferred.

Key Responsibilities

Quality Control Management

- Lead QC operations for Raw Materials, Packaging Materials, In-process, Finished Products, Stability Samples, and Water Testing.
- Ensure timely testing and release of products in line with business requirements.
- Monitor laboratory productivity, compliance, and turnaround time (TAT).
- Review and approve analytical reports, specifications, SOPs, test methods, and protocols.

Regulatory Compliance & Audits
- Ensure compliance with MHRA, EU-GMP, WHO-GMP, ANVISA, and other global regulatory requirements.
- Lead regulatory inspections, customer audits, and corporate audits.
- Ensure effective implementation of Data Integrity (ALCOA+) principles.
- Review and approve OOS, OOT, deviations, CAPA, change controls, and risk assessments.

Stability & Laboratory Systems
- Manage stability programs as per ICH guidelines.
- Ensure qualification, calibration, and maintenance of laboratory instruments.




- Drive laboratory compliance and continuous improvement initiatives.

Leadership & People Management
- Lead and develop QC teams by providing technical guidance and coaching.
- Drive performance management, succession planning, and capability development.
- Ensure optimum manpower utilization and resource planning.

Cross Functional Support
- Partner with QA, Production, Engineering, Warehouse, Regulatory Affairs, and R&D; teams.
- Provide support during product validation, technology transfer, troubleshooting, and investigations.

Educational Qualification
- M.Sc. (Chemistry/Analytical Chemistry) / M. Pharma.

Experience
- 15 to 20 years of experience in Pharmaceutical Quality Control.
- Minimum 5 years in a leadership role managing QC laboratories.
- Mandatory experience in OSD manufacturing facilities.
- Exposure to Sterile/Injectable facilities will be an added advantage.
- Proven experience in handling regulatory audits of MHRA, EU-GMP, WHO-GMP, and ANVISA.

Technical Competencies
- HPLC, GC, Dissolution, UV, FTIR, ICP-MS and other analytical techniques.
- OOS/OOT Investigation Management.
- Stability Study Management.
- Data Integrity & GMP Compliance.
- Method Validation and Verification.
- Regulatory Audit Handling.
- Laboratory Compliance and Quality Systems.

Behavioural Competencies
- Strategic Leadership
- Decision Making
- Problem Solving
- Team Development
- Stakeholder Management
- Change Management
- Strong Communication Skills

Preferred Candidate Profile: Strong Quality Control leader from a regulated OSD manufacturing workplace , with exposure to Sterile/Injectable operations , and hands-on experience handling international regulatory inspections including MHRA, EU-GMP, and ANVISA.

📌 Quality Control Lead (Pune)
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