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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Validation Consultant (Jama Connect System) – Senior
As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Senior Consultant actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you will consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.
The Chance
We are seeking an experienced Validation Consultant – Computerized System Validation (CSV) to lead validation and compliance for JAMA connect system for global pharmaceutical clients. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for business process transformation and operational excellence.
Your Key Responsibilities
Support validation and compliance activities across GxP and non-GxP systems, aligning with global regulatory requirements and client objectives.
Hands-on experience in validating Jama Connect and managing end-to-end requirements lifecycle, traceability, and CSV documentation (URS, FRS, Traceability Matrix) while ensuring adherence to GxP and regulatory compliance standards.
Define and drive CSV/CSA strategies, enabling transition from traditional validation to risk-based assurance models.
Integrate va
📌 RC - REGULATORY COMPLIANCE - CSV - Jama Connect System - Senior (India)
🏢 EY
📍 India