Aniket Roy
Global Quality at Novartis | Ex-Sandoz | Ex-Biocon
- Role
- Global Lab Systems Deployment Specialist, Global Digital Qc Coe at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Aniket Roy
A seasoned professional with more than 7 years of experience in Quality, IT Quality…
Experience
Global Lab Systems Deployment Specialist, Global Digital Qc Coe
May 2025 — Present · Hyderabad, IN
Contribute to the implementation and deployment of Laboratory IT systems across manufacturing and testing sites globally, delivering scalable, compliant, and business-aligned digital lab solutions that support transformation in Life Sciences.• Act as a strategic liaison between IT and Business, translating operational requirements into technical deliverables.• Manage the end-to-end project lifecycle—from planning and stakeholder alignment to execution, validation, and post-deployment support.• Oversee Computer System Validation (CSV) activities in compliance with GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and other global GxP regulations.• Develop and review validation documentation, including URS, FS, FRA, IQ, OQ, PQ, and TRM, ensuring traceability and audit readiness.• Support establishment and maintenance of global documentation related to the systems in scope (e.g. SOPs, WIs, user guides, etc) • Support risk management, defect resolution, CAPA, Investigations, and test management, maintaining quality and compliance throughout the deployment process.• Cultivate strong stakeholder engagement and cross-functional collaboration, ensuring transparent communication and timely decision-making across global teams.• Promote continuous improvement and innovation to enhance system efficiency and compliance.
Education
Methodist School, Dankuni, West Bengal
ISC - Higher Secondary Education, Science
2011 — 2013
Don Bosco School, Liluah, West Bengal
ICSE - Secondary Education, General Studies
1999 — 2011
KIIT - Kalinga Institute of Industrial Technology
M.Tech - Dual Degree, Biotechnology
KIIT - Kalinga Institute of Industrial Technology
B.Tech, Biotechnology
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