Senior Executive - Quality Assurance (QMS)

Lupin; Pithampur; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Lupin in India is seeking a senior Quality Assurance professional for Sterile Ophthalmic facilities. The role oversees quality systems, regulatory compliance, and continuous improvement across manufacturing. You will lead audits, investigations, and CAPA programs to ensure product quality and compliance.

Ideal candidates bring 12+ years in pharmaceutical QA, strong documentation, analytical skills, and excellent stakeholder management to drive compliance with cGMP and global quality standards.

Qualifications

• 12+ years of experience in Pharmaceutical Quality Assurance (Sterile Ophthalmic Facility).
• Strong expertise in QMS and regulatory compliance.
• Strong analytical and problem-solving abilities.
• Excellent communication and stakeholder coordination.

Responsibilities

• Manage Quality Systems: deviations, CAPA, change control, OOS/OOT, market complaints.
• Lead APQR, PER, and CPV reviews.
• Review and approve SOPs, BMRs/BPRs, validation protocols and reports.
• Ensure audit readiness and track audit observations.
• Maintain cGMP, GxP compliance.
• Drive continuous quality improvement across manufacturing and QA.
• Support regulatory inspections and audits through investigations.

Skills

Quality Management Systems

Regulatory compliance

Analytical skills

Documentation

Communication

Coordination

Stakeholder management

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

• Min 12 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.