RC-REGULATORY COMPLIANCE-CSV-Staff

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We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go.

Join EY and help to build a better working world.

EY – GDS Consulting – Enterprise Risk - ER – Regulatory Compliance – CSV - Staff

At EY, we're all in to shape your future with confidence.

We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world.

As part of our EY-ER Regulatory Compliance team, you will support clients by understanding their business needs and contributing to the delivery of high-quality solutions in alignment with EY guidelines and methodologies. In your role as a Staff Consultant, you will assist in maintaining strong internal and external relationships, contribute to project execution with attention to quality and timelines, and support operational efficiency. You'll proactively collaborate with cross-functional teams, raise potential risks to senior team members, and participate in internal initiatives that foster learning and innovation.

The opportunity

We are looking for a proactive and detail-oriented Staff Consultant to support Computerized System Validation (CSV) initiatives across global pharmaceutical clients. This role offers hands-on experience with validated systems such as Veeva Vault QMS, TrackWise, SAP, LIMS, ELN, MES, and Regulatory Information Management Systems (RIMS). You'll contribute to validation activities, system assessments, and compliance programs while collaborating with cross-functional teams in a regulated environment.

Your Key Responsibilities

• Contribute to CSV activities using GAMP 5 Life Cycle methodology.
• Support gap assessments and remediation for legacy systems to align with current validation policies.
• Assist in software classification, IT risk assessments, and mitigation planning.
• Troubleshoot application-related issues and recommend solutions in collaboration with QA, IT, and business teams.
• Participate in business process transformation programs involving systems like Veeva Vault QMS, TrackWise, SAP, LIMS, ELN, MES, Documentum, ValGenesis, Argus, and RIMS.
• Create and review validation deliverables including VP, URS, RA, IQ / OQ / PQ, TM, TR, and Traceability Matrix.
• Collaborate with cross-functional teams to meet project timelines and quality standards.
• Support audit readiness and documentation for inspections and compliance reviews.
• Maintain strong client relationships and contribute to internal initiatives and knowledge sharing.
• Stay updated on industry trends, regulatory changes, and EY service offerings.
• Participate in cross-skilling and training programs to enhance domain and technical capabilities.

Skills And Attributes For Success

Good-to-Have Skills

To qualify for the role, you must have

What We Look For

What Working At EY Offers

At EY, we're dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer :

EY | Building a better working world

EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets.

Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow.

EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.

Skills Required

Sap, trackwise , Lims, Hipaa, eln , Vendor Management, Capa, Change Control, Regulatory Affairs, data integrity, Mcc, Incident Management, Qms, Pharmaceutical Quality Control, Quality Assurance, Mes, anvisa , Deviation