Join our Business Consulting Risk team in Mumbai as a Consultant focused on Digital Risk within the TMT sector. This role is crucial for helping Technology, Media, and Entertainment (TMT) organizations navigate industry convergence, drive agile strategies, and achieve operational excellence. You'll contribute to protecting client data, brand, and reputation while enabling M&A strategies that foster growth and innovation.

EY Consulting is at the forefront of transforming businesses through people, technology, and innovation. Our client-centric approach ensures we address the most strategic problems, driving long-term value. Within Consulting, we focus on Business Consulting, Technology Consulting, and People Advisory Services. We specialize in identifying and managing risks to help clients achieve their future business objectives.

As part of our CNS - RISK - DIGITAL RISK team, you will focus on Computer System Validation (CSV) and IT Risk. You will assess computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures and regulatory requirements. Key responsibilities include creating and reviewing validation deliverables such as user requirements, system specifications, validation plans, SOPs, IQ/OQ/PQ, and summary reports.

You will provide guidance on validation activities for GxP relevant computer systems, collaborating with project teams to integrate quality and compliance throughout the system lifecycle. Your role involves reviewing and approving validation work products, ensuring thorough planning and timely completion of deliverables. Experience with ITRA (IT Risk Assessment) is essential as clients increasingly rely on technology for growth and require assistance in protecting assets and minimizing disruption.

To excel in this role, you should have a Bachelor of Technology in Computer Science, a Bachelor of Pharmacy, or a Bachelor of Computer Applications. We require 2 to 13 years of hands-on experience in Computer System Validation (CSV), particularly with Enterprise Applications like LIMS, ERPs, LMS, RPA, and CTMS. A strong understanding of FDA regulations and cGxP (cGMP, cGDP, cGAMP, cGLP) standards, along with experience in risk-based validation, is essential.

Familiarity with validation/testing tools such as HP ALM or Azure DevOps (ADO) would be advantageous. We seek individuals who can collaborate effectively across departments, demonstrating a practical approach to problem-solving and delivering insightful solutions. Candidates should be agile, curious, mindful, and possess the ability to maintain positive energy while adapting creatively to challenges.