Consultant - Business Consulting Risk - CHS - CNS - Risk - Digital Risk - Gurgaon
EY
EY
Embark on a career in Business Consulting with EY's Digital Risk team in Gurgaon. EY fosters a culture of continuous learning, offering opportunities for growth and freedom to innovate, helping you build your ideal professional path.
As a Consultant, you will contribute to transforming businesses through innovative technology solutions and a client-centric approach. You'll focus on solving complex strategic problems and driving long-term value for clients within the Consumer Products and Health Sciences sectors, or within our broader CNS Risk domain.
This role is integral to EY Consulting's mission of building a better working world by managing the interplay between risk and opportunity. You will engage with clients to address key risk areas, enhance resilience, and ensure compliance in an increasingly digital landscape.
Develop and execute Computer System Validation (CSV) across the entire system lifecycle, including requirements, risk assessment, and testing. Ensure compliance with 21 CFR Part 11 regulations for electronic records and signatures, focusing on audit trails, access controls, and data integrity. Prepare and execute critical validation deliverables such as validation plans, URS, FRS, and IQ/OQ/PQ protocols. Identify system control gaps and propose effective remediation strategies aligned with industry and regulatory standards. Assess technology risks for businesses to support sustainable growth and provide trusted communications on internal control and regulatory compliance.
A Bachelor of Technology in Computer Science is required for this role. You must possess a minimum of 3 years of experience in Quality Assurance & Testing. Proven experience in computer system validation (CSV) is essential, covering the full system lifecycle. Demonstrated working knowledge of 21 CFR Part 11 requirements and familiarity with GxP-regulated computerized systems are crucial. Candidates should possess a practical approach to problem-solving, adaptability, and the ability to work collaboratively across client departments while adhering to commercial and legal requirements.
EY Global Delivery Services ( EY GDS)
Management Consulting