Senior Manager - Validation Lead

Responsibilities

• Plan and monitor activities related to the quality engineering section and new quality projects
• Review and approve qualification master plans and annual/monthly re-qualification schedules
• Ensure timely execution and closure of qualification and re-qualification protocols for equipment, personnel, and utilities
• Review and approve URS, DQ, SAT, FAT, IQ, OQ, and PQ protocols, reports, and summaries
• Manage inter-departmental communication to ensure timely completion of qualification activities
• Oversee Quality Management System (QMS) documents including deviations, CAPA, and change controls
• Perform internal and external audits as required by the site QA team
• Identify training needs and provide necessary training for Quality Engineering personnel
• Prepare monthly and quarterly CQ reports for the QE department

Requirements

• B. Pharm. or M. Pharm. degree
• 15+ years of relevant experience in validation or quality engineering
• Deep expertise in URS, DQ, SAT, FAT, IQ, OQ, and PQ protocols
• Strong knowledge of Quality Management Systems (QMS)
• Proven experience in conducting internal and external auditing

About the Company

Sun Pharmaceutical Industries Ltd is a leading global pharmaceutical company dedicated to providing high-quality medicines. We foster an environment where employees can grow, take charge of their professional journeys, and thrive within a supportive, collaborative community.