Regulatory & Quality Systems Specialist (GxP)

Aspen Pharma Group

Dubai

On-site

AED 180,000 - 260,000

Full time

6 days ago
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Job summary

Aspen Pharma Group seeks an Group Analyst to manage regulatory and quality systems like eQMS, RIMS, and DMS. You will ensure validated state, secure operations, and alignment with global standards such as GxP and 21 CFR Part 11.

You will collaborate with Regulatory, Quality, IT, and vendors to support access, training, documentation, and system changes, maintaining data integrity and compliance across audits.

Qualifications

  • Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or related field.
  • ITIL Foundation (required).
  • Veeva Vault certification (required).
  • GxP / CSV / 21 CFR Part 11 training (preferred).
  • 3-5+ years administering Regulatory, Quality, or other GxP‑validated systems.

Responsibilities

  • Administer Regulatory & Quality systems (eQMS, RIMS, DMS, Audit platforms).
  • Manage user accounts, roles, permissions, and security groups.
  • Configure workflows, rules, fields, and metadata per designs.
  • Lead system upgrades/releases per vendor cycles.
  • Develop minor enhancements and reports.
  • Maintain validated state and data integrity.

Skills

Analytical thinking
Troubleshooting
Attention to detail
Excellent communication

Education

Bachelor’s degree in CS/IT/Life Sciences
ITIL Foundation
Veeva Vault certification

Tools

eQMS platforms
RIMS systems
Document Control systems
Audit & Compliance apps

Job description

Aspen Pharma Group seeks an Group Analyst to manage regulatory and quality systems like eQMS, RIMS, and DMS. You will ensure validated state, secure operations, and alignment with global standards such as GxP and 21 CFR Part 11.

You will collaborate with Regulatory, Quality, IT, and vendors to support access, training, documentation, and system changes, maintaining data integrity and compliance across audits.

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