Executive – Equipment Qualification & Computer System Validation
Location: Pune Biotech, Maharashtra, India
Company: Lupin
Date Posted: February 8, 2026
Employment Type: Full-Time
Industry: Pharmaceutical R&D | Quality Systems | Equipment Validation
About the Role
Lupin is seeking a detail-oriented Executive to join its Biotech division in Pune, focusing on equipment qualification and computer system validation. The role involves reviewing and monitoring IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, ensuring compliance with regulatory and quality standards.
This position is ideal for candidates with experience in equipment qualification, validation documentation, and quality management system (QMS) activities in a regulated pharmaceutical environment.
Experience Required
2 to 5 years of relevant experience in:
Equipment qualification (IQ, OQ, PQ)
Computer system validation
Quality Management System (QMS) operations, including Change Control, Deviations, and CAPA
Educational Qualification (Mandatory)
Bachelor’s or Master’s degree in Pharmacy, Biotechnology, or Life Sciences
Key Responsibilities
Equipment Qualification & Validation
Review and monitor Equipment Qualification protocols and final reports
Evaluate qualification documentation prepared by vendors or third parties for instruments integrated with equipment
Ensure proper execution and documentation of IQ, OQ, and PQ activities
Collaborate with cross-functional teams for validation planning and execution
Quality Management System (QMS) Activities
Handle QMS-related activities including:
Change Control
Deviations
Corrective and Preventive Actions (CAPA)
Ensure timely documentation, review, and closure of quality records
Compliance & Documentation
Maintain regulatory-compliant validation records
Ensure all qualification and validation activities meet cGMP and internal audit requirements
Support audit readiness and regulatory inspections
Required Skills & Competencies
Strong knowledge of equipment qualification (IQ, OQ, PQ) and computer system validation
Understanding of QMS procedures and regulatory compliance
Attention to detail and accuracy in documentation
Strong analytical, organizational, and problem-solving skills
Effective communication and collaboration with cross-functional teams
Core Competencies
Process Discipline & Compliance
Technical Expertise in Validation
Analytical Thinking & Problem-Solving
Collaboration & Stakeholder Management
Result Orientation
Why Join Lupin Biotech?
Work on state-of-the-art equipment qualification and validation projects
Gain exposure to global cGMP standards and regulatory compliance
Contribute to high-quality biologics R&D programs
Build expertise in equipment and computer system validation within a regulated pharmaceutical environment
Equal Opportunity Statement
Lupin is committed to providing equal employment opportunities in recruitment, promotion, compensation, and professional development. All qualified applicants will be considered in accordance with applicable employment regulations.
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