Join our TMT Business Consulting Risk team as a Senior Consultant in Bangalore, focusing on Digital Risk. We empower Technology, Media, and Telecommunications (TMT) organizations to navigate industry convergence, drive transformation, and achieve sustainable growth. You'll contribute to creating exceptional customer and employee experiences while safeguarding data, brand, and reputation. Our approach fosters value creation through M&A strategies, building future-ready powerhouses.

EY Consulting is dedicated to building a better working world through people, technology, and innovation. We partner with clients to solve their most strategic challenges, focusing on driving long-term value. Our service lines include Business Consulting (Performance Improvement and Risk Consulting), Technology Consulting, and People Advisory Services.

We specialize in helping clients identify and manage risks, enabling informed, long-term decisions that align with business strategies and objectives. Our key focus areas include Enterprise Risk & Resilience, Internal Audit, Compliance, Technology Risk, and Financial Services Risk, ensuring clients can respond effectively to evolving challenges.

As a Senior Consultant in Digital Risk, you will perform assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory requirements. You will create and review crucial CSV deliverables, 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 embed quality and compliance throughout the system lifecycle. Your role will involve reviewing and approving computer system validation work products, ensuring the thoroughness of validation planning and timely completion of deliverables.

To excel in this role, a Bachelor of Technology in Computer Science is required. We seek candidates with 2 to 13 years of hands-on experience in Computer System Validation (CSV), particularly with Enterprise Applications such as LIMS, ERPs, LMS, RPA, and CTMS. Experience within an FDA-regulated environment, coupled with a strong understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation methodologies, is essential.

Proficiency in quality and compliance is a must. Experience with validation or testing tools like HPALM or Azure DevOps (ADO) will be considered an advantage. Additionally, prior experience in training validation resources is a plus. We are looking for individuals who thrive in collaborative environments, possess a practical, problem-solving approach, and deliver insightful solutions. Adaptability, curiosity, and sustained positive energy are key attributes for success.