Instrument Qualification Expert
REQ-10085008
Aug 07, 2026
LOC_IN
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 in global instrument-related initiatives and ensure the availability of certified reference measuring instruments, including review and assessment of external calibration results against instrument requirements.
Minimum Experience
- Bachelor's or master's degree in chemistry, Pharmaceutical Sciences, Analytical Sciences, Engineering, or a related scientific discipline.
- Minimum 2 years of hands-on experience in analytical instrument qualification, calibration, validation, and lifecycle management within a GMP-regulated environment.
- Strong understanding of GMP principles, data integrity requirements, and analytical instrument lifecycle management, including qualification, maintenance, and compliance processes.
- Excellent scientific, communication, and presentation skills, with the ability to effectively collaborate across Quality, IT, laboratory, and external vendor teams.
- Strong organizational skills, quality mindset, and teamwork capabilities, with a proven ability to manage multiple priorities while maintaining a high level of compliance and operational excellence.
Role Requirements
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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DIV_GD
Development
LOC_IN
Hyderabad (Office)
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
FCT_RD
Full time
Regular
No
