Job Summary

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 Consultant - 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 master plan or equivalent documents aligned to corporate QMS and current GxP expectations. Define scope, deliverables, and acceptance criteria for releases and site deployments.
- Regulatory Compliance : Ensure alignment with 21 CFR Part 11 , EU Annex 11 , Annex 15 , ICH Q9/Q10 , data integrity principles (ALCOA+), and applicable regional guidance. Monitor regulatory changes and translate them into pragmatic updates to validation practices.
- Lifecycle Documentation : Own and author or oversee key lifecycle documents: User Requirements (URS), Functional/Design Specifications (FS/DS), Configuration Specifications, Risk Assessments (FMEA/HAZOP where applicabl

📌 RC-REGULATORY COMPLIANCE-CSV-MES Validation-Senior Professional (Kolkata)
🏢 EY
📍 Kolkata