Senior Executive - Quality Assurance

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.