Join our Business Consulting Risk team in Mumbai, focusing on the Technology, Media, and Telecommunications (TMT) sector. We empower TMT organizations to navigate industry convergence, develop agile strategies, and achieve operational excellence. Our work involves safeguarding data, brands, and reputations, and enabling M&A strategies that drive value and reduce risk.

EY Consulting is dedicated to transforming businesses through people, technology, and innovation. We address our clients' most strategic challenges with a client-centric approach, aiming to deliver long-term value. Within EY Consulting, we specialize in Business Consulting, Technology Consulting, and People Advisory Services. We help clients identify and manage risks, ensuring their strategies align with future business objectives. Our focus areas include Enterprise Risk, Technology Risk, and Financial Services Risk, utilizing transformative and agile methodologies.

As part of the Digital Risk team, you will contribute to Computer System Validation (CSV) initiatives, which are crucial for managing technology-related risks. You will assess computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, best practices, and regulatory requirements.

Key responsibilities include creating and reviewing CSV deliverables such as user requirements, system specifications, validation plans, qualification plans, SOPs, IQ/OQ/PQ, traceability matrices, design specifications, and validation summary reports. You will provide guidance and oversight for validation activities on GxP-relevant computer systems and collaborate with project teams to integrate quality and compliance throughout the system lifecycle. Approving computer system validation work products and ensuring timely completion of deliverables are also essential aspects of this role.

To excel in this role, you should possess hands-on experience in Computer System Validation (CSV) within enterprise applications like LIMS, ERPs, LMS, RPA, and CTMS. A strong understanding of the FDA-regulated environment and cGxP (cGMP, cGDP, cGAMP, cGLP) standards, along with risk-based validation principles, is essential.

We seek individuals with a Bachelor of Technology in Computer Science, Bachelor of Pharmacy, or Bachelor of Computer Applications. Experience in the range of 2 to 13 years is required. Familiarity with validation and testing tools such as HP ALM or Azure DevOps (ADO) is advantageous, as is prior experience in training validation resources. The ability to work collaboratively, solve complex problems with practical solutions, and maintain an agile, curious, and creative approach is highly valued.