Advance your career in Business Consulting within the dynamic TMT sector, focusing on Digital Risk. This role is based in Mumbai and offers a unique opportunity to address the evolving challenges in Technology, Media, and Telecommunications. You will help organizations transform, enhance customer experiences, and achieve operational excellence while protecting their data and brand.

EY Consulting is dedicated to building a better future through innovation and people-powered solutions. Our client-centric approach resolves complex strategic issues, driving long-term value. We focus on Enterprise Risk, Technology Risk, and Financial Services Risk, helping clients navigate opportunities and mitigate potential downsides.

As a Consultant in Digital Risk, you will conduct Computer System Validation (CSV) for Life Sciences clients, ensuring compliance with internal procedures, industry best practices, and regulatory standards. Your responsibilities include assessing computer systems and processes, creating and reviewing critical validation documents such as user requirements, system specifications, validation plans, IQ/OQ/PQ, and validation summary reports.

You will guide and oversee validation activities for GxP-relevant computer systems, collaborating closely with project teams to integrate quality and compliance throughout the system lifecycle. This involves reviewing and approving validation work products to ensure thorough planning and timely completion of deliverables.

The ideal candidate will possess 2 to 13 years of experience in Quality and Compliance, with hands-on expertise in computer system validation for enterprise applications like LIMS, ERPs, LMS, RPA, and CTMS. A strong understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation principles within an FDA-regulated environment is essential.

We are seeking individuals with the ability to collaborate effectively across departments, applying a practical and insightful approach to problem-solving. Strong analytical skills, adaptability, creativity, and a positive, energetic mindset are highly valued. Experience with validation/testing tools such as HPALM or Azure DevOps, and experience in training validation resources, are considered advantageous.