Join our dynamic Business Consulting Risk team in Mumbai, focusing on the Technology, Media, and Telecommunications (TMT) sector. You'll play a crucial role in helping TMT companies navigate industry convergence, transform their operations, and achieve sustainable growth. This position is ideal for experienced professionals seeking to leverage their expertise in digital risk and build a better working world.

EY Consulting is at the forefront of transforming businesses through innovative solutions and a client-centric approach. We address the most strategic challenges faced by our clients, focusing on driving long-term value. Our expertise spans Business Consulting, Technology Consulting, and People Advisory Services, enabling us to offer comprehensive support.

Within CNS - RISK - DIGITAL RISK, we specialize in identifying and managing the interplay between potential opportunities and inherent risks. Our focus areas include Enterprise Risk, Technology Risk, and Financial Services Risk, equipping clients with the agility to respond effectively to evolving market landscapes.

As a Consultant in Digital Risk, you will be responsible for assessing computer systems and processes within Life Sciences clients to ensure compliance with internal procedures, industry best practices, and regulatory mandates. Your duties will involve creating and reviewing critical Computer System Validation (CSV) documentation, including user requirements, system specifications, validation plans, and summary reports.

You will provide expert guidance and oversight for validation activities on projects involving GxP-relevant computer systems. Collaborating closely with project teams, you will ensure quality and compliance are integrated throughout the system lifecycle. Furthermore, you will review and approve validation work products, guaranteeing thoroughness in planning and timely delivery of all validation documentation.

To excel in this role, you should possess a Bachelor of Technology in Computer Science, a Bachelor of Pharmacy, or a Bachelor of Computer Applications degree. The ideal candidate will have 2 to 13 years of hands-on experience in Computer System Validation (CSV), particularly with Enterprise Applications such as LIMS, ERPs, LMS, RPA, and CTMS.

Demonstrated experience in FDA-regulated environments with a strong understanding of cGxP standards (cGMP, cGDP, cGAMP, cGLP) and risk-based validation approaches is essential. While not mandatory, experience with validation/testing tools like HP ALM or Azure DevOps (ADO), and experience in training validation resources, will be considered significant advantages. We seek individuals who can collaborate effectively, solve complex problems with practical solutions, and maintain an agile, curious, and creative mindset.