Senior Consultant - Business Consulting Risk - TMT - CNS - RISK - DIGITAL RISK - Bangalore
EY
EY
Join our dynamic Digital Risk team as a Senior Consultant in Bangalore, focusing on the Technology, Media, and Telecommunications (TMT) sector. In this role, you'll leverage your expertise to help TMT organizations navigate industry convergence, overcome competitive challenges, and implement agile strategies for sustainable growth.
We empower TMT companies to enhance employee and customer experiences, retain top talent, and achieve operational excellence. Our work involves safeguarding data, brand reputation, and enabling strategic M&A activities that create value and mitigate risk. Become part of a team that is building a better working world through innovation and client-centric solutions.
Your primary responsibilities will involve performing thorough assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, industry best practices, and regulatory requirements.
You will be instrumental in creating and reviewing critical Computer System Validation (CSV) deliverables, including user requirements, system specifications, validation plans, and summary reports. Providing guidance and oversight for validation activities on GxP-relevant computer systems is key. You'll collaborate closely with project teams to integrate quality and compliance throughout the system lifecycle, and review/approve validation work products to ensure timely and thorough completion.
To excel in this role, you need a Bachelor of Technology in Computer Science and 2 to 13 years of hands-on experience in Computer System Validation (CSV) within an FDA-regulated environment.
Demonstrated experience with enterprise applications such as LIMS, ERPs, LMS, RPA, and CTMS is essential. A strong understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation methodologies is required.
Experience with validation/testing tools like HP ALM or Azure DevOps (ADO), and prior experience training validation resources, are considered advantageous for this position. We seek individuals with a collaborative spirit, a practical approach to problem-solving, and the ability to deliver insightful solutions.
EY Global Delivery Services ( EY GDS)
Media & Entertainment