Computer System Validation (CSV) Professional

EY India is looking for experienced Computer System Validation (CSV) professionals to join our team and contribute to regulatory compliance and quality assurance in enterprise applications.

Who We Are Looking For:

- Experience: 3-12 years in Enterprise Application Computer System Validation (CSV)

- Big 4/Consulting experience is a plus!

Key Skills:

- Hands-on end to end experience in CSV and STLC principles.

- Strong knowledge of regulations and guidelines such as 21 CFR Part 11, GxP, and GAMP 5.

- Expertise in tools like Azure DevOps, TIMS, HP ALM, and Leapwork.

- Familiarity with enterprise validation such as Salesforce, SAP ECC/HANA, Veeva Vault, LIMS, QMS, ELN, DMS, PLM, and CTMS.

- Experience in Change Management, Deviation/NC & CAPA Management.

Soft Skills:

- Strong written and verbal communication skills.

- Ability to work in a fast-paced, compliance-driven environment.

Priority: Immediate joiners preferred