Head of Quality Control

Job Summary

The Quality Control Head is responsible for leading and managing the Quality Control function to ensure that all raw materials, in-process materials, finished products, and stability samples comply with regulatory standards and company quality policies. The role ensures adherence to cGMP, regulatory requirements (USFDA, MHRA, WHO, EU GMP, etc.), and internal quality systems for pharmaceutical and chemical manufacturing operations.

Key Responsibilities

1. Leadership & Strategy

- Lead, mentor, and develop the QC team including Managers, Executives, Analysts, and Microbiologists. - Establish quality objectives aligned with corporate strategy. - Drive continuous improvement initiatives within QC laboratories.

2. Laboratory Management

- Oversee testing of Raw Materials (RM), Packing Materials (PM), In-Process Samples, Finished Goods (FG), and Stability Samples. - Ensure timely review and approval of analytical reports and Certificates of Analysis (COA). - Manage calibration and maintenance of laboratory instruments (HPLC, GC, UV, IR, etc.). - Ensure compliance with Data Integrity (ALCOA+) principles.

3. Regulatory & Compliance

- Ensure compliance with USFDA, EU GMP, MHRA, WHO, and other international regulatory requirements. - Handle regulatory audits and customer inspections; respond to observations . - Review and approve SOPs, Specifications, STPs, Protocols, and Validation Reports.

4. Documentation & Systems

- Maintain laboratory documentation as per cGMP guidelines. - Review and approve OOS (Out of Specification), OOT (Out of Trend), Deviations, CAPA, and Change Controls. - Ensure effective implementation of LIMS and other digital QC systems.

5. Stability & Validation

- Oversee stability study programs as per ICH guidelines. - Support analytical method validation, transfer, and verification activities. - Ensure compliance with cleaning validation and process validation requirements.

6. Budget & Resource Management

- Prepare and manage QC department budget. - Ensure optimal utilization of manpower, materials, and laboratory resources.

Educational Qualifications

- M.Sc. / M.Pharm in Analytical Chemistry / Pharmaceutical Chemistry or related discipline. - Ph.D. (preferred).

Experience

- 15–20+ years of experience in Quality Control within a regulated pharmaceutical/API manufacturing environment. - Minimum 5–7 years in a leadership role handling regulatory audits.