EY is a global leader in assurance, tax, transaction, and advisory services, dedicated to building a better working world. We cultivate a culture of continuous learning, offering training, opportunities, and creative freedom to help you grow. At EY, we focus on your potential and provide motivating experiences to help you become your best professional self. This role is a Consultant position within the CHS-Business Consulting Risk-CNS - Risk - Digital Risk practice in Gurgaon.

Your primary responsibilities will involve technical excellence in computer system validation (CSV) throughout its lifecycle. This includes requirements definition, risk assessment, testing, and documentation. You will ensure compliance with 21 CFR Part 11, understanding audit trails, access controls, and data integrity. Key tasks include preparing and executing validation deliverables like validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices. You will also identify gaps in system controls and propose remediation strategies aligned with regulatory standards.

To qualify for this role, you must possess a Bachelor of Technology in Computer Science and have a minimum of 3 years of experience in Quality Assurance & Testing. We seek individuals who can collaborate effectively across client departments, adhering to commercial and legal requirements. A practical, problem-solving approach with the ability to deliver insightful solutions is essential. We value candidates who are agile, curious, mindful, adaptable, and creative, demonstrating sustained positive energy.