Executive

Job Description

Join Lupin Limited's dynamic IT Operations team as an Executive dedicated to ensuring the highest standards of compliance and system integrity across our computerized software systems. In this role, you will take a proactive stance in validating computer system software and sustaining its validated status in strict accordance with Standard Operating Procedures (SOPs) aligned with current Good Manufacturing Practices (cGMP) guidelines. Your expertise will be crucial in identifying and addressing gaps in existing practices through structured mitigation plans executed within agreed timelines.

This position entails active participation in internal, external, and regulatory audits, collaborating closely with cross-functional teams to ensure full compliance and readiness. As a key contributor to management review meetings, you will provide critical updates on project progress, compliance status, and actionable insights to drive continual improvement.

You'll be responsible for conducting regular audits of IT systems to identify discrepancies, implement effective solutions, and manage escalations and system downtimes while overseeing the change control processes to uphold system integrity. Coordination with Original Equipment Manufacturers (OEMs) and vendors will be integral to ensuring timely support and resolution of any operational issues.

Security is paramount—your role includes establishing and maintaining robust IT security controls and safe working environments. You will oversee comprehensive backup, restoration, and archival procedures for electronic data associated with computerized systems, ensuring documentation and schedules comply with applicable SOPs. Managing user accounts and access rights within computerized systems will also fall under your purview, emphasizing adherence to security and data protection policies.

The successful candidate will bring a strategic, detail-oriented mindset with strong collaboration skills, driving process excellence and innovation while fostering a culture of continuous development and customer-centricity. This role offers the opportunity to work at the intersection of IT operations and regulatory compliance, contributing meaningfully to Lupin Limited's commitment to quality and operational excellence.

Work Experience

Candidates should possess 8 to 10 years of progressive experience in IT operations, specifically with expertise in computerized system validation within regulated environments. Experience working in compliance with cGMP guidelines and proven involvement in audit processes are essential. Prior exposure to coordinating with vendors/OEMs and managing IT security controls in pharmaceutical or similar industries will be highly advantageous.

Education

Competencies