This role offers a unique opportunity within EY's Business Consulting Risk practice, focusing on the TMT sector in Mumbai. You will contribute to building a better working world by transforming businesses through innovative solutions. EY Consulting assists TMT organizations in navigating industry convergence, enhancing competitiveness, and implementing agile growth strategies. We help clients create exceptional employee and customer experiences, protect their data and reputation, and pursue value-generating M&A strategies.

The CNS - RISK - DIGITAL RISK team specializes in identifying and managing risks to enable long-term strategic decision-making and prevent negative impacts on business objectives. We focus on Enterprise Risk, Technology Risk, and Financial Services Risk to help clients build resilience and achieve sustainable growth.

As a Consultant in Digital Risk, your key responsibilities will involve performing Computer System Validation (CSV) for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory requirements. You will create and review critical CSV deliverables such as user requirements, system specifications, validation plans, qualification plans, SOPs, IQ/OQ/PQ, traceability matrices, design specifications, and validation summary reports.

Additionally, you will provide guidance and oversight for validation activities on projects involving GxP relevant computer systems, collaborating closely with project teams to embed quality and compliance throughout the system lifecycle. You will also review and approve computer system validation work products, ensuring thorough planning and timely completion of deliverables.

To excel in this role, you should possess hands-on experience in Computer System Validation (CSV) on 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 experience in risk-based validation, is essential.

Experience with validation/testing tools such as HP ALM or Azure DevOps (ADO) is considered an advantage. The ideal candidate will have a practical, collaborative approach to problem-solving, delivering insightful and practical solutions. We are looking for agile, curious, mindful individuals who can maintain positive energy and demonstrate adaptability and creativity.