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 leadthe Quality Control function and ensure compliance with cGMP requirements,regulatory standards, and quality systems. The role will be responsible formanaging chemical, instrumental stability testing activities, ensuringtimely 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 bepreferred.

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 RD 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: Solid Quality Controlleader from a regulated OSD manufacturing environment, with exposureto Sterile/Injectable operations, and hands-on experience handlinginternational regulatory inspections including MHRA, EU-GMP, and ANVISA. Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 QC Lead (Mulshi)
🏢 Emcure Pharmaceuticals
📍 Mulshi