Join EY's Business Consulting team as an Associate Consultant, specializing in Digital Risk within the TMT sector. This role offers a unique opportunity to contribute to shaping a better working world by transforming businesses through people, technology, and innovation. You'll work with leading TMT organizations to enhance customer experiences, achieve operational excellence, and navigate the complexities of digital transformation and risk management.

EY fosters a culture that prioritizes your growth, providing extensive training, opportunities, and creative freedom. We focus on your potential and offer fulfilling experiences to help you become your best professional self. Your career journey is yours to build with limitless potential.

Perform comprehensive assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, industry best practices, and regulatory mandates.

Develop and review 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.

Provide expert guidance and oversight for validation activities on projects involving GxP-relevant computer systems.

Collaborate closely with project team members to integrate quality and compliance elements throughout the system lifecycle.

Review and approve computer system validation work products, ensuring thorough planning and timely completion of deliverables.

A graduate degree in Computer Science (B.Tech) or Pharmacy (B.Pharmacy) from a reputable university is required.

Possess 2 to 12 years of experience in Computer System Validation (CSV).

Demonstrate hands-on experience with 21 CFR and CSV principles.

Experience in a FDA-regulated environment with a solid understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation methodologies is essential.

Excellent written and verbal communication, interpersonal, networking, teaming, and problem-solving skills are crucial. Must be highly flexible, adaptable, and creative, with a proactive approach to staying current with industry practices and emerging technologies.