Join our dynamic Business Consulting team in Mumbai, focusing on Digital Risk within the TMT sector. We empower Technology, Media, and Telecommunications organizations to navigate industry convergence, transform their strategies, and achieve sustainable growth.

Our consulting services help TMT companies enhance employee and customer experiences, optimize operations, and protect their valuable data, brand, and reputation. We also support M&A initiatives aimed at creating long-term value and driving innovation.

As part of EY Consulting, you'll contribute to building a better working world by leveraging people, technology, and innovation to solve our clients' most strategic challenges. Our client-centric approach ensures we deliver lasting value and address critical risks.

As a Consultant in Digital Risk, your key responsibilities will include:

- Performing comprehensive assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, best practices, and regulatory mandates. - Developing and reviewing crucial Computer System Validation (CSV) deliverables, such as user requirements, system specifications, Validation Plans, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrices, Design Specifications, 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 integrate quality and compliance seamlessly into the system lifecycle. - Reviewing and approving computer system validation work products, ensuring the thoroughness of validation planning and timely completion of deliverables.

To excel in this role, you must possess:

- A Bachelor of Technology in Computer Science, a B.Pharmacy, or a Bachelor of Computer Applications. - Between 2 to 13 years of hands-on experience in Computer System Validation (CSV). - Proven experience in Quality and Compliance, with practical application on Enterprise Applications (e.g., LIMS, ERPs, LMS, RPA, CTMS). - A strong understanding of working within an FDA-regulated environment and familiarity with cGxP (cGMP, cGDP, cGAMP, cGLP) standards, including risk-based validation methodologies. - An ability to work collaboratively, delivering services across departments while adhering to commercial and legal requirements. - A practical, problem-solving approach, coupled with the ability to deliver insightful and actionable solutions. - Agility, curiosity, mindfulness, and a creative, adaptable mindset.

Experience with validation/testing tools like HP ALM or Azure DevOps (ADO), and experience in training validation resources, are considered advantageous.