Group Administrator: Regulatory and Quality Applications
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DescriptionJob Purpose: The Group Administrator: Regulatory and Quality Applications is an operational role in the Group Digital Technology team, responsible for providing day-to-day application support, issue resolution, and user assistance for the Regulatory and Quality Application which includes primarily Veeva and related systems like Esko Pulse, TVT, Argus PV and Track wise Digital. This role is support-focused, ensuring that Regulatory Affairs teams can operate efficien
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Overview
DescriptionJob Purpose: The Group Administrator: Regulatory and Quality Applications is an operational role in the Group Digital Technology team, responsible for providing day-to-day application support, issue resolution, and user assistance for the Regulatory and Quality Application which includes primarily Veeva and related systems like Esko Pulse, TVT, Argus PV and Track wise Digital. This role is support-focused, ensuring that Regulatory Affairs teams can operate efficiently and in compliance using the Regulatory IT platforms. The Administrator acts as a first line of support for users, manages incidents, service requests and changes, coordinates with internal Regulatory Application Analyst / Specialist, Internal IT Teams and Vendor (like Veeva) for issue escalation, and plays a critical role in maintaining system stability and user satisfaction. Basic Veeva system configuration and reporting skills are essential.Job Requirements: Bachelor s degree in computer science, Information Technology, Life Sciences, or related field. ITIL Foundation (a plus). Veeva Vault certification (required). 3+ years administering Regulatory, Quality, or other GxP validated systems. Strong knowledge of GxP / CSV / 21 CFR Part 11 Experience supporting one or more of the following highly desirable: o eQMS platforms (Veeva QMS) o RIMS systems o Document Control systems (SharePoint DMS, Veeva Qdocs, OpenText) o Audit & Compliance applications Experience maintaining validated systems (URS, IQ/OQ/PQ, trace matrices). Familiarity with workflow design, role based security, reporting tools, and configuration rules Strong understanding of GxP requirements, data integrity, ALCOA+, and validation processes. Experience analysing and interpreting regulatory guidelines and applying them to system operations. Strong knowledge of role-based access administration and security controls. Application configuration, workflow administration, and user access management. Incident, probl
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