Join our dynamic Business Consulting Risk team in Mumbai, specializing in the Technology, Media & Entertainment, and Telecommunications (TMT) sector. We empower TMT organizations to navigate industry convergence, transform their strategies, and achieve agile growth. Our focus areas include enhancing employee and customer experiences, protecting data and reputation, and driving M&A strategies to build future industry powerhouses.

EY Consulting is at the forefront of transforming businesses through people, technology, and innovation. We address our clients' most strategic challenges, focusing on long-term value creation. Our expertise spans Business Consulting, Technology Consulting, and People Advisory Services. We help clients proactively identify and manage risks, ensuring their future business strategy and objectives remain on track. Our key focus areas include Enterprise Risk, Technology Risk, and Financial Services Risk.

As a Consultant within the Digital Risk team, your primary responsibility will be to ensure the integrity and compliance of computer systems, particularly for Life Sciences clients. This involves conducting thorough assessments of computer systems and processes against internal procedures, leading practices, and regulatory mandates. You will be instrumental in creating and reviewing critical Computer System Validation (CSV) deliverables, including User Requirements, System Specifications, Validation Plans, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability Matrices, Design Specifications, and Validation Summary Reports.

You will also provide expert guidance and oversight for validation activities on projects involving GxP-relevant computer systems. Collaborating closely with project team members, you will ensure that quality and compliance are seamlessly integrated into the system lifecycle. Additionally, you will review and approve computer system validation work products, ensuring comprehensive validation planning and timely delivery of all validation documentation.

To excel in this role, you should possess a Bachelor of Technology in Computer Science, Bachelor of Pharmacy, or Bachelor of Computer Applications degree. We are seeking candidates with 2 to 13 years of hands-on experience in Computer System Validation (CSV) within Enterprise Applications such as LIMS, ERPs, LMS, RPA, and CTMS. A strong understanding of the FDA-regulated environment, including cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation methodologies, is essential.

Ideal candidates will demonstrate an ability to collaborate effectively, providing services across multiple client departments while adhering to commercial and legal requirements. You should possess a practical approach to problem-solving, delivering insightful and actionable solutions. We value individuals who are agile, curious, mindful, and possess sustained positive energy, coupled with adaptability and creativity in their approach. Experience with validation/testing tools like HP ALM or Azure DevOps (ADO), and experience in training validation resources, will be considered advantageous.