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Group Administrator – Regulatory & Quality Applications

Aspen Pharma Group · Doubaï

جديد
Mid 🇬🇧 English
Veeva Vault Veeva QMS Esko Pulse TVT Argus PV SharePoint OpenText ITIL GxP CSV 21 CFR Part 11

وصف الوظيفة

About the role

The Group Administrator for Regulatory and Quality Applications provides day‑to‑day support for the digital platforms used by Regulatory Affairs and Quality teams. Working within the Group Digital Technology team, you will ensure these GxP‑validated systems run smoothly, enabling compliance and efficient operations.

Key responsibilities

  • Act as first‑line support for users of Veeva Vault, Esko Pulse, TVT, Argus PV, Trackwise Digital and related tools.
  • Manage incidents, service requests, and change requests following ITIL processes.
  • Coordinate with internal Regulatory Application Analysts, IT teams, and external vendors (e.g., Veeva) for issue escalation and resolution.
  • Maintain system stability through configuration, workflow administration, and role‑based access management.
  • Document SOPs, work instructions, validation artefacts, and system logs.

Required profile

  • Bachelor’s degree in Computer Science, IT, Life Sciences or related field.
  • 3+ years experience administering GxP‑validated regulatory or quality systems.
  • Veeva Vault certification (required) and ITIL Foundation knowledge (a plus).
  • Strong understanding of GxP, CSV, 21 CFR Part 11, data integrity (ALCOA+), and validation lifecycles.

Required skills

  • Veeva Vault and Veeva QMS configuration.
  • Experience with Esko Pulse, TVT, Argus PV, Trackwise Digital.
  • Document control platforms such as SharePoint and OpenText.
  • Workflow design, role‑based security, and reporting tool configuration.
  • Incident, problem, change, and request management using ITIL frameworks.

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Aspen Pharma Group

Doubaï