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).
Solid expertise in Quality Management Systems and regulatory compliance.
Robust analytical, problem-solving, and documentation skills.
Excellent communication, coordination, and stakeholder management abilities.

📌 Senior Executive Quality Assurance Pithampur
🏢 LUPIN
📍 Pithampur