This role is for a Consultant focused on Business Consulting within the Risk domain, specifically for the TMT (Technology, Media & Entertainment, and Telecommunications) sector, with a specialization in CNS - RISK - DIGITAL RISK. The opportunity involves helping TMT organizations navigate industry convergence, evolve their strategies, and achieve operational excellence while protecting their brand and data. EY Consulting aims to build a better working world by transforming businesses through people, technology, and innovation, focusing on client-centric solutions to solve strategic problems.

As a Consultant, you will be involved in Computer System Validation (CSV) and IT Risk Assessment (ITRA) for Life Sciences clients. Your responsibilities will include assessing computer systems and processes for compliance with internal procedures, leading practices, and regulatory requirements. You will create and review CSV deliverables such as user requirements, system specifications, Validation Plans, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability Matrices, Design Specs, and validation summary reports. Providing guidance and oversight for validation activities on GxP-relevant computer systems and ensuring quality and compliance throughout the system lifecycle are key aspects of this role. You will also review and approve computer system validation work products.

To be successful in this role, you should possess hands-on experience in Quality and Compliance, with a strong background in computer system validation for Enterprise Applications like LIMS, ERPs, LMS, RPA, and CTMS. A solid understanding of the FDA-regulated environment and cGxP (cGMP, cGDP, cGAMP, cGLP) standards, along with risk-based validation methodologies, is essential. While not mandatory, experience with validation/testing tools such as HP ALM or Azure DevOps (ADO), and experience in training validation resources, would be advantageous. A Bachelor of Technology in Computer Science, B.Pharm, or Bachelor of Computer Applications is required, coupled with 2 to 13 years of experience in CSV. The ideal candidate will demonstrate a collaborative approach, practical problem-solving skills, and the ability to deliver insightful solutions, exhibiting agility, curiosity, and adaptability.