Join EY Consulting as a Senior Consultant in Digital Risk, focusing on the Technology, Media, and Telecommunications (TMT) sector. This role is based in Bangalore and offers an exciting opportunity to help TMT organizations navigate industry convergence, transform their strategies, and achieve operational excellence. You'll be instrumental in protecting client data, brand, and reputation, while enabling M&A strategies that drive value and reduce risk.

EY Consulting is dedicated to building a better working world by leveraging people, technology, and innovation. Our client-centric approach tackles the most strategic challenges, driving long-term value. We are comprised of Business Consulting, Technology Consulting, and People Advisory Services. Within Business Consulting, we focus on Performance Improvement and Risk Consulting.

Our Digital Risk practice assists clients in identifying and managing the interplay between potential risks and rewards. We guide them in making informed long-term decisions to safeguard their organization's ability to meet future business objectives. Key areas of focus include Enterprise Risk and Resilience, Internal Audit, Compliance, Internal Controls, and Technology Risk.

As a Senior Consultant in Computer System Validation (CSV), you will conduct assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, best practices, and regulatory mandates. You will create and review critical CSV documentation, including user requirements, system specifications, Validation Plans, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability Matrices, Design Specifications, and validation summary reports.

Provide expert guidance and oversight for validation activities on projects involving GxP-relevant computer systems. Collaborate closely with project team members to integrate quality and compliance elements throughout the system lifecycle. Review and approve computer system validation work products, ensuring thorough validation planning and timely delivery of all documentation.

To excel in this role, you should possess a Bachelor of Technology in Computer Science or Pharmacy. A minimum of 2 to 13 years of hands-on experience in Computer System Validation (CSV) for Enterprise Applications such as LIMS, ERPs, LMS, RPA, and CTMS is required. Experience within an FDA-regulated environment, with a solid understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation methodologies, is essential.

We are looking for individuals who can collaborate effectively across multiple client departments, adhering to commercial and legal requirements. A practical, problem-solving approach to complex issues, delivering insightful and actionable solutions, is key. Ideal candidates are agile, curious, mindful, adaptable, and creative, maintaining positive energy throughout their work.