Senior Consultant - Business Consulting Risk - TMT - CNS - RISK - DIGITAL RISK - Bangalore
EY
EY
Join our team as a Senior Consultant specializing in Business Consulting Risk within the TMT sector, focusing on Digital Risk. You'll play a pivotal role in helping Technology, Media, and Telecommunications (TMT) organizations navigate industry convergence, develop agile strategies, and achieve enterprise-wide operational excellence. We empower clients to protect their data, brand, and reputation while enabling M&A strategies that drive value and transform them into leaders of the future. This role is crucial for building a better working world through innovation and technology-driven solutions.
As a Senior Consultant, your key responsibilities will involve performing Computer System Validation (CSV) assessments for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory requirements. You will create and review critical CSV deliverables such as user requirements, validation plans, qualification protocols, SOPs, and validation summary reports. Additionally, you'll provide guidance and oversight for validation activities on GxP-relevant computer systems, collaborate closely with project teams to integrate quality and compliance throughout the system lifecycle, and review/approve validation work products to ensure thoroughness and timely completion.
To excel in this role, you must possess hands-on experience in Computer System Validation (CSV) on Enterprise Applications (LIMS, ERPs, LMS, RPA, CTMS). A strong background in FDA-regulated environments with a solid understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation is essential. Experience with validation/testing tools like HPALM and Azure DevOps (ADO) is a significant advantage. We are looking for individuals with 2 to 13 years of relevant experience, a Bachelor of Technology in Computer Science, and the ability to work collaboratively, solve complex problems, and deliver insightful solutions with agility and creativity.
EY Global Delivery Services ( EY GDS)
Media & Entertainment