
Sun Pharmaceutical Industries Ltd., the fourth largest specialty generic pharmaceutical company globally and India’s leading drugmaker by market capitalization, has announced an opening for the senior leadership position of Quality Assurance Head (OSD) at its Mohali site.
The site QA Head will steer operational quality strategies, reinforce compliance frameworks, and oversee cross-functional assurance teams across Oral Solid Dosage (OSD) manufacturing lines.
Position Summary & Core Mandate
The incumbent will serve as the primary site authority accountable for the overall quality, integrity, and regulatory compliance of all products manufactured and dispositioned at the facility. Key facets of the role span In-Process Quality Assurance (IPQA), Quality Management Systems (QMS), Analytical Quality Assurance (AQA), QA-Validation, and documentation lifecycles.
Detailed Responsibilities & Operational Scope
- Quality Strategy & Governance: Formulate, execute, and monitor operational roadmaps in strict alignment with Sun Pharma’s corporate quality guidelines, GXP standards, and international statutory commitments.
- Batch Disposition & Product Release: Assume direct accountability for commercial batch disposition, ensuring every drug product released into global markets meets defined safety, identity, strength, purity, and quality metrics.
- Robust QMS Oversight: Manage deviations, Out of Specification (OOS) trends, market complaints, and product failure investigations, driving rigorous Root Cause Analysis (RCA) and time-bound Corrective and Preventive Actions (CAPA).
- Audit Preparedness & Health Authority Inspections: Maintain “always inspection-ready” compliance across the facility for both internal quality reviews and stringent regulatory agency audits (such as USFDA, MHRA, and national regulators). Lead comprehensive site-wide corrective action plans addressing inspection observations.
- Risk Management & Validation Protocols: Direct change management workflows, qualification protocols, and Quality Risk Management (QRM) assessments across production processes and analytical infrastructure.
- People Leadership & Capability Building: Direct departmental resource allocation, conduct Quality Management Reviews (QMR), establish performance metrics, and foster ongoing professional development and cGMP training for site personnel.
Candidate Eligibility Criteria
- Designation: QA Head (OSD)
- Educational Qualification: Bachelor of Pharmacy (B.Pharm) / Master of Pharmacy (M.Pharm)
- Experience Required: 18 to 20 years of core experience in pharmaceutical quality assurance leadership, specifically within formulation and oral solid dosage manufacturing environments.
- Location: Mohali, Punjab (Quality Control / Quality Operations)
