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EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance - CSV – MES - Manager
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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 Manager 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 Prospect
We are seeking an experienced Validation Manager – Computerized System Validation (CSV) to lead validation and compliance for defining and executing the validation strategy for Manufacturing Execution System (MES) deployments using PAS‑X across regulated and business critical computerized systems 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
Validation Strategy & Planning: Develop the end‑to‑end validation approach for PAS‑X implementations, including CSV/CSA strategy, risk assessments, and the validation m
📌 RC-REGULATORY COMPLIANCE-CSV (India)
🏢 EY
📍 India
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