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 programs for employees and contractors, ensuring appropriate qualification and training on analytical instruments, GMP procedures, and related systems.
- Represent ARD

📌 Instrument Qualification Expert (Hyderabad)
🏢 Novartis
📍 Hyderabad