Associate Engagement Manager (GxP Validation Expert)

While technology is the heart of our business, a global and diverse culture is the heart of our success. We love our people and we take pride in catering them to a culture built on transparency, diversity, integrity, learning and growth.

If working in an environment that encourages you to innovate and excel, not just in professional but personal life, interests you- you would enjoy your career with Quantiphi! Role: Associate Engagement Manager - GxP Validation Expert Experience Level: 5-12 Years Work location: Mumbai, Bengaluru, Trivandrum

Role & Responsibilities: The ideal candidate will lead and execute GxP validation activities across various infrastructure components. This includes:

• Infrastructure Qualification: Leading IQ, OQ, and PQ for cloud platforms (AWS, Azure, GCP), virtualized environments, network components, and storage/backup systems.
• Validation Deliverables: Developing and reviewing key validation documents (Validation Plan, URS, FS/DS/CS, Risk Assessments, Traceability Matrix, Validation Summary Report) using a GAMP 5 risk-based approach.
• Hands-on Execution: Performing protocol execution with meticulous evidence capture (logs, screenshots, system outputs).