10 Aug
|
Emcure Pharmaceuticals
|
India
10 Aug
Emcure Pharmaceuticals
India
Job Description – 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 solid 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, P
📌 Quality Control Lead (India)
🏢 Emcure Pharmaceuticals
📍 India