Group Analyst: Regulatory and Quality Applications (Dubai)
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Key skills for this role
About the Role
Aspen Holdings seeks a Group Analyst to administer, configure, and support regulatory and quality systems such as eQMS, RIMS, and Document Control. The role ensures systems are validated and compliant with GxP, 21 CFR Part 11, ISO 9001, and ISO 13485.
Key Skills for This Role
Responsibilities
- Perform day to day administration and configuration of Regulatory & Quality systems (eQMS, RIMS, DMS, Audit platforms)
- Manage user accounts, roles, permissions, and security groups
- Configure workflows, rules, fields, and metadata according to approved designs
- Ensure systems are available and functioning for Quality and Regulatory processes
- Maintain validation documentation including URS, IQ/OQ/PQ, change controls, and risk assessments
- Provide Tier 2 and 3 support for application issues
- Develop and deliver user training, onboarding materials, and system guides
- Coordinate with vendors for issue resolution and enhancement support
- Generate reports, dashboards, metrics, and compliance indicators
Requirements
- Bachelor's degree in Computer Science, Information Technology, Life Sciences, or related field
- ITIL Foundation certification (required)
- Veeva Vault certification (required)
- 3 5+ years administering Regulatory, Quality, or other GxP validated systems
- Experience with eQMS, RIMS, Document Control, or Audit & Compliance applications
- Strong understanding of GxP requirements, data integrity, ALCOA+, and validation processes
Full Job Posting
Job Purpose
- Operational role within Group Digital Technology team responsible for administration, configuration, and support of systems for regulatory, quality, and compliance operations.
- Serves as application specialist supporting enterprise platforms such as eQMS, RIMS, Document Control, Audit & Compliance systems, and other regulatory/quality tools.
Key Performance Areas
- Perform day to day administration and configuration of Regulatory & Quality systems (eQMS, RIMS, DMS, Audit platforms).
- Manage user accounts, roles, permissions, and security groups; configure workflows, rules, fields, and metadata.
- Technical lead for system upgrades/releases per Vendor quarterly release cycles.
- Work on minor enhancement/backlog initiatives for regulatory applications.
- Conduct routine system checks, maintenance tasks, and support validated state upkeep.
- Ensure systems are available for Quality and Regulatory processes (submissions, CAPAs, audits, deviations, SOPs, training).
- Support data integrity controls including audit trails, electronic signatures, and controlled documents.
- Maintain validation documentation including URS, IQ/OQ/PQ, change controls, and risk assessments.
- Support internal/external audits, inspections, and regulatory reviews.
- Provide Tier 2 and 3 support for application issues; troubleshoot workflow failures, configuration errors, access issues.
- Develop and deliver user training, onboarding materials, and system guides.
- Coordinate with vendors for issue resolution, small changes, or enhancement support.
Job Requirements
- 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.
- Experience with eQMS platforms (Trackwise, Veeva QMS, Esko Pulse), RIMS systems, Document Control systems, or 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.
- Knowledge of FDA 21 CFR Part 11, EMA, ICH, and relevant global regulatory guidelines.
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