Senior Executive - Quality Assurance

Job description

Key Responsibilities • Manage Quality Systems, including: • Deviations • CAPA (Corrective and Preventive Actions) • Change Control • OOS/OOT Investigations • Market Complaints • Lead APQR (Annual Product Quality Review), PER, and CPV review and compliance activities. • Review and approve SOPs, BMRs/BPRs, validation protocols, reports, and other quality documentation. • Ensure audit readiness and drive audit compliance activities, including observation tracking and closure. • Maintain compliance with cGMP, GxP, and applicable regulatory requirements. • Drive continuous quality improvement initiatives across manufacturing and quality systems. • Support regulatory inspections and internal/external audits through effective investigation and compliance management. Candidate Profile • 12 to 14 years of experience in Pharmaceutical Quality Assurance (Sterile Ophthalmic Facility). • Strong expertise in Quality Management Systems and regulatory compliance. • Strong analytical, problem-solving, and documentation skills. • Excellent communication, coordination, and stakeholder management abilities.