Group Analyst: Regulatory and Quality Applications

Aspen Holdings

Job Description

Roles & Responsibilities

Desired Candidate Profile

• 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 supporting one or more of the following highly desirable:
  • eQMS platforms (Trackwise, Veeva QMS, Esko Pulse)
  • RIMS systems
  • Document Control systems (SharePoint DMS, Veeva Qdocs, OpenText)
  • 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.
• 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, problem, change, and request management using ITIL frameworks.
• Strong analytical and troubleshooting capability for application and workflow issues.
• Documentation discipline, including SOPs, work instructions, validation artefacts, and system logs.
• Ability to work collaboratively with Quality, Regulatory, and cross-functional stakeholders.
• Strong analytical and methodical problem solving skills.
• High attention to detail and disciplined approach to documentation and configuration control.
• Excellent communication skills, particularly in translating system concepts into business language.
• Ability to remain calm and effective under pressure or audit conditions.
• Proactive, collaborative, and committed to continuous improvement.
• High level of accountability and ownership of allocated tasks.
• Deep understanding of Regulatory Affairs and Quality Management processes.
• Knowledge of eQMS, RIMS, Document Control, and Audit & Compliance systems.
• Strong understanding of validation lifecycle, SOP standards, and compliance frameworks.
• Knowledge of integration patterns between enterprise systems (e.g., Veeva, SAP, Argus).
• Understanding of electronic records/e-signature regulations and data integrity requirements.