- Bangalore, Karnataka, India +1 more
- Senior
- 6+ years
Senior Tech Specialist, Cloud Engineering
Locations (2)
- Bangalore, Karnataka, India
- India
Responsibilities
- Drive IT platform and application governance throughout the system development lifecycle, including design, development, release, change management, and retirement, ensuring regulatory compliance
- Plan and execute Computer System Validation (CSV) and Computer Software Assurance (CSA) activities using risk-based GAMP 5 methodologies
- Lead qualification activities for systems, platforms, cloud environments, and sandboxes, including IQ/OQ/PQ
- Prepare and review validation documentation such as Validation Plans, Risk Assessments, URS, Functional Specifications, Traceability Matrices, Test Scripts, and Validation Summary Reports
- Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and applicable pharmaceutical regulatory standards