RC-REGULATORY COMPLIANCE-QMS - CA-Veeva-Senior

EY

5–7 yrs Kolkata Full Time Hybrid (office + remote)
EY logo
Posted : 2 weeks ago Actively Hiring

Job description

Join EY as a Senior Veeva Vault QMS Developer and contribute to shaping the future of global life sciences clients. You will be instrumental in designing, configuring, and implementing Veeva Vault Quality Management Systems (QMS) within highly regulated environments. This role is perfect for professionals with extensive Veeva Vault technical expertise, a solid grasp of GxP compliance, and a proven track record of delivering validated, scalable QMS solutions.

Collaborate closely with Quality, IT, Validation, and Business stakeholders to transform quality and compliance requirements into robust Vault configurations. Ensure these align seamlessly with global regulatory standards and client quality strategies, playing a key role in building a better working world.

Responsibilities

Configure, customize, and deploy Veeva Vault QMS modules, including Deviations, CAPA, Change Control, and Audit Management, to align with client-specific quality processes and regulatory mandates. Design and implement essential system elements like workflows, object lifecycles, security roles, page layouts, and reports. Support data migration initiatives using Vault Loader and APIs, ensuring data integrity and traceability.

Facilitate system integrations between Veeva Vault and other enterprise systems, and author comprehensive system documentation. Provide expert troubleshooting and impact analysis to resolve system issues efficiently. Ensure compliance with global regulatory standards such as GxP, CSV/CSA, and 21 CFR Part 11, and mentor junior developers to foster knowledge sharing and team growth.

Qualifications

A Bachelor’s degree in Computer Science, Information Technology, or a related technical field is required. Demonstrable proficiency in configuring the Veeva Vault platform, covering objects, fields, roles, workflows, lifecycles, and reporting tools is essential. Familiarity with Veeva APIs, Vault Loader, and integration tools for data migration and system interoperability is expected.

Experience in Agile/Scrum environments is crucial. A strong understanding of GxP compliance, CSV/CSA methodologies, and 21 CFR Part 11 requirements in validated environments is necessary. Excellent analytical, problem-solving, communication, client interaction, and documentation skills are vital for success in this role.

Essential Skills

Veeva Vault QMSVeeva Vault DevelopmentQuality Management Systems (QMS)DeviationsCAPAChange ControlAudit ManagementQuality Risk Management (QRM)Supplier QualityComplaintsGxP ComplianceCSV/CSA21 CFR Part 11Veeva APIsVault LoaderSystem DocumentationValidation ProtocolsUser GuidesTroubleshootingImpact AnalysisRelease ManagementAgile/ScrumClient InteractionCommunication SkillsProblem-Solving

Good to Have

Business DevelopmentAI/AutomationProcess OptimizationVeeva Associate Administrator Certification

More Details

RoleRC-REGULATORY COMPLIANCE-QMS - CA-Veeva-Senior
IndustryManagement Consulting, Information Technology & Services
DepartmentSoftware Development, Quality Assurance
Employment TypeFull Time, Hybrid (office + remote)

About the Company

EY Global Delivery Services ( EY GDS) logo

EY Global Delivery Services ( EY GDS)

Management Consulting

RC-REGULATORY COMPLIANCE-QMS - CA-Veeva-Senior at EY | SkillMX | SkillMX