Join a global leader in assurance, tax, transaction, and advisory services where we foster a culture of continuous learning and development. At EY, we empower you to build your career, offering unlimited potential and fulfilling experiences. We are seeking a Consultant specializing in Business Consulting Risk within our CHS (Consumer Products and Healthcare) and CNS (Technology Consulting) domains, focusing on Digital Risk in Gurgaon.

Our CHS sector supports clients in the retail, agri-business, health sciences, and wellness industries, helping them navigate digital transformation and enhance customer engagement. The CNS - Risk - Digital Risk team collaborates with clients to manage risks, ensuring their business strategies and objectives are met through innovative solutions.

As a Consultant in Digital Risk, your responsibilities will include driving technical excellence through computer system validation (CSV) across the entire system lifecycle. You will be responsible for requirements, risk assessment, testing, and preparing comprehensive validation documentation. A key aspect of this role involves ensuring compliance with 21 CFR Part 11, understanding electronic records and signatures, audit trails, access controls, and data integrity.

You will also prepare and execute validation deliverables such as validation plans, URS, FRS, IQ/OQ/PQ protocols, and traceability matrices. Familiarity with GxP-regulated computerized systems and regulatory inspection expectations is crucial. Identifying system control gaps and proposing remediation strategies aligned with industry standards will be a significant part of your contribution.

To be successful in this role, you must possess a Bachelor of Technology in Computer Science and have at least 3 years of experience in Quality Assurance & Testing. We are looking for individuals who can collaborate effectively across client departments, adhering to commercial and legal requirements. A practical approach to problem-solving and delivering insightful solutions is essential.

Ideal candidates are agile, curious, mindful, and maintain positive energy. Adaptability and creativity in your approach to challenges are highly valued. Join us to shape the future with confidence and build a better working world.