RC-REGULATORY COMPLIANCE-CSV-Staff

• 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

• Experience in Quality & Compliance advisory within the Life Sciences domain.
• Experience working with VLMS tools.
• Domain knowledge in Pharmaceutical Quality Control, Quality Assurance, and Regulatory Affairs.
• Strong understanding of CSV principles, GAMP 5, and System Development Life Cycle (SDLC).
• Familiarity with global regulations: USFDA 21 CFR Part 11, EU GMP Annex 11, WHO, HIPAA, TGA, MCC, Anvisa.
• Exposure to enterprise IT systems: Veeva Vault QMS, TrackWise, SAP, LIMS, ELN, MES, Documentum, ValGenesis, Argus, RIMS.
• Hands-on experience with Quality System elements: Deviation, CAPA, Change Control.
• Basic understanding of Data Integrity, Incident Management, and Vendor Management.
• Strong interpersonal, documentation, and presentation skills.

Good-to-Have Skills

• Exposure to business development and client engagement strategies.
• Experience supporting audits and inspections.
• Experience in process optimization and operational efficiency initiatives.
• Ability to align technology with business transformation goals.
• Analytical thinking, adaptability, and decision-making skills.

To qualify for the role, you must have

• B.E/B.Tech (Electronics, Telecommunications, Computer Science) or
• Postgraduate in Science (preferably Chemistry/Biochemistry)
• 1-3 years of experience in a Big 4 or multinational life sciences organization
• Strong communication and collaboration skills
• Good interpersonal skills; Good written and presentational skills

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY, were dedicated to helping our clients, from startups 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:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way thats right for you