Regulatory IT & Quality Apps Specialist

Aspen Pharma Group

Dubai

On-site

AED 240,000 - 360,000

Full time

5 days ago

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Job summary

Aspen Pharma Group in Dubai seeks a Group Administrator: Regulatory and Quality Applications to provide day‑to‑day support for Regulatory IT platforms including Veeva Vault, Esko Pulse, TVT, Argus PV and TrackWise Digital. You will manage incidents, user access, and change requests to keep systems compliant and stable.

The role requires 3+ years with GxP‑validated systems, Veeva Vault certification, and strong documentation.

Qualifications

Bachelor’s degree in computer science, IT, 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 eQMS platforms (Veeva QMS), RIMS, Document Control, Audit & Compliance apps.
Experience maintaining validated systems (URS, IQ/OQ/PQ, trace matrices).
Knowledge of integration patterns between enterprise systems (e.g., Veeva, SAP, Argus).
Understanding of electronic records/e-signature regulations and data integrity requirements.

Responsibilities

Provide 1st and 2nd line support for users of the Regulatory applications (Registrations, Submissions, Archive, CRM and Safety).
Monitor support queues, investigate and resolve incidents, log service requests, and ensure timely follow-up and closure.
Troubleshoot issues like document upload failures, user access problems, metadata mismatches, and workflow errors.
Ensure SLAs are met and tickets are closed on time (Incidents, Requests, Change & Problem).
Follow Problem Management and provide RCA for major incidents.
Follow GxP and CSV methods to keep systems in a validated state.