Join our dynamic Business Consulting Risk team as a Senior Consultant, focusing on Digital Risk within the Technology, Media, and Telecommunications (TMT) sector. This role offers a unique opportunity to help TMT organizations navigate industry convergence, transform their strategies, and achieve operational excellence. You will play a pivotal role in safeguarding 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 through innovation and a client-centric approach. We address strategic problems by identifying and managing the interplay between potential risks and opportunities. Our services span Enterprise Risk, Technology Risk, and Financial Services Risk, providing comprehensive solutions to our clients.

As a Senior Consultant specializing in Computer System Validation (CSV) within Digital Risk, your key responsibilities will include:

- Conducting assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, leading practices, and regulatory requirements. - Developing and reviewing critical CSV deliverables, such as user requirements, system specifications, Validation Plans, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability Matrix, Design Specs, and validation summary reports. - Providing expert guidance and oversight for validation activities on projects involving GxP relevant computer systems. - Collaborating closely with project team members to embed quality and compliance throughout the system lifecycle. - Reviewing and approving computer system validation work products, ensuring thorough planning and timely completion of deliverables.

To excel in this role, you must possess:

- A Bachelor of Technology (B.Tech) in Computer Science or Pharmacy. - Between 2 to 13 years of hands-on experience in Computer System Validation (CSV). - Proven experience in Quality and Compliance, with practical application of CSV on Enterprise Applications like LIMS, ERPs, LMS, RPA, and CTMS. - Familiarity with FDA-regulated environments and a strong understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards, along with risk-based validation methodologies. - Experience working collaboratively, providing services across multiple client departments while adhering to commercial and legal requirements. - A practical, problem-solving approach with the ability to deliver insightful and actionable solutions. Candidates should demonstrate agility, curiosity, mindfulness, and adaptability.