EY Consulting is at the forefront of transforming businesses through innovation and technology. We focus on creating long-term client value by tackling their most pressing strategic challenges. Our consulting services span Business Consulting (including Performance Improvement and Risk Consulting), Technology Consulting, and People Advisory Services.

We empower clients to navigate the complex interplay of risks and rewards, enabling strategic decisions that safeguard their future business objectives. Our key focus areas include Enterprise Risk Management, Technology Risk, and Financial Services Risk. We help organizations build resilience, ensure compliance, and leverage technology to achieve sustainable growth.

In this role, you will leverage your expertise in computer system validation (CSV) throughout the entire system lifecycle, from requirements and risk assessment to testing and documentation. You will ensure compliance with 21 CFR Part 11 for electronic records and signatures, including managing audit trails, access controls, and data integrity.

Key responsibilities 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 effective remediation strategies aligned with regulatory and industry standards, particularly within GxP-regulated environments.

We seek professionals with a Bachelor of Technology in Computer Science and a minimum of 3 years of experience in Quality Assurance & Testing. The ideal candidate possesses proven experience in computer system validation (CSV) and a strong understanding of 21 CFR Part 11 requirements.

Essential attributes include the ability to collaborate effectively across client departments, adhering to commercial and legal guidelines. You should demonstrate a practical, insightful, and agile approach to problem-solving, coupled with creativity and adaptability. A positive, curious, and mindful mindset is crucial for success in this role.