Senior Executive - Quality Assurance

Lupin; Pithampur; On-site; INR 2,400,000 - 3,600,000; Full time

Job summary

Lupin in India seeks an experienced Pharmaceutical Quality Assurance professional (Sterile Ophthalmic Facility) to lead quality systems, CAPA, change control, and audit readiness. You will review SOPs, validation protocols and regulatory documents, ensuring compliance and effective investigations.

The role demands 12+ years in QA, strong documentation and stakeholder management, and excellent communication across teams and regulatory bodies.

Qualifications

• 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.

Responsibilities

• Manage Quality Systems, including deviations, CAPA, Change Control, OOS/OOT investigations, and market complaints.
• Lead APQR, 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.

Skills

Quality Management Systems

Regulatory compliance

Analytical skills

Documentation skills

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.