Join our Business Consulting Risk team in Mumbai as a Consultant focused on the Technology, Media, and Telecommunications (TMT) sector. This role is integral to Digital Risk within EY Consulting, where we help clients navigate industry convergence and transformation. You'll contribute to building a better working world by advising TMT organizations on creating compelling employee and customer experiences, managing risks, and achieving operational excellence.

Our TMT practice helps clients adapt to evolving market dynamics, from content distribution shifts to service provider tech transformations. We focus on enabling sustainable growth, protecting brand reputation, and executing M&A strategies that drive value and position companies for future technological leadership. You will be part of a client-centric team solving strategic problems through innovation and technology.

As a Consultant specializing 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. Your responsibilities include creating and reviewing critical CSV deliverables such as user requirements, system specifications, validation plans, qualification plans, SOPs, IQ/OQ/PQ, traceability matrices, design specifications, and validation summary reports.

You will provide guidance and oversight for validation activities on projects involving GxP relevant computer systems. Collaborating closely with project team members, you'll ensure appropriate quality and compliance elements are integrated into the system lifecycle. Additionally, you will review and approve computer system validation work products, verifying the thoroughness of validation planning and ensuring timely completion of deliverables. Experience in training validation resources is an advantage.

To excel in this role, you should possess 2 to 13 years of experience in Quality and Compliance, with hands-on Computer System Validation (CSV) experience on Enterprise Applications like LIMS, ERPs, LMS, RPA, and CTMS. A strong understanding of the FDA regulated environment and cGxP (cGMP, cGDP, cGAMP, cGLP) standards, along with risk-based validation principles, is essential.

We are seeking individuals with a Bachelor of Technology in Computer Science, Bachelor of Pharmacy, or Bachelor of Computer Applications. Experience with validation/testing tools such as HPALM or Azure DevOps (ADO) will be considered an added advantage. The ideal candidate demonstrates an ability to work collaboratively, provide insightful solutions to complex problems, and exhibit agility, curiosity, and adaptability in their approach to work.