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.
- Strong analytical, problem-solving, and documentation skills.
- Excellent communication, coordination, and stakeholder management abilities.

📌 Senior Executive - Quality Assurance (Pithampur)
🏢 LUPIN
📍 Pithampur