This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. Summary Performs, supports or supervises instrument related qualification activities and change control including issuing, review and LU approval of corresponding documentation. Serves as the point of contact between local QA and local ARD for inquiries regarding instrument related processes and represents Analytical research & development in related networks, committees, and initiatives, if necessary, and collaborates with Qualification Experts and similar roles across line functions. Responsible for instrument lifecycle activities like calibration and requalification. Serves on site level as the point of contact between QA, ARD laboratories, other Qualification Experts (QE), and service provider (if applicable). About the Role Major Accountabilities Oversee GMP analytical instrument lifecycle activities within ARD, including instrument qualification, maintenance, calibration, testing,



and coordination with vendors, QA, and IT functions. Maintain the GMP instrument management system and analytical instrument database, ensuring compliance with applicable regulations, validation requirements, and data integrity standards. Develop, review, and update instrument-related procedures, guidelines, validation documentation, and validation master plans as required. Support regulatory inspections, audits, and laboratory walkthroughs by coordinating preparation activities, addressing observations, and ensuring timely follow-up actions. Provide technical expertise and troubleshooting support for analytical instrument-related deviations, issues, investigations, and continuous improvement initiatives. Act as a liaison between local QA and ARD teams, ensuring alignment on GMP instrument management practices, technical agreements, qualifications, and compliance requirements. Coordinate training program

📌 Instrument Qualification Expert (India)
🏢 Novartis
📍 India