Group Administrator Regulatory and Quality Applications (Durban North) at Aspen Pharma Group

JOP PURPOSE:

• The Group Administrator: Regulatory and Quality Applications is an operational role in the Group Digital Technology team, responsible for providing day-to-day application support, issue resolution, and user assistance for the Regulatory and Quality Application, which includes primarily Veeva and related systems like Esko Pulse, TVT, Argus PV, and Trackwise Digital. This role is support-focused, ensuring that Regulatory Affairs teams can operate efficiently and in compliance using the Regulatory IT platforms. The Administrator acts as a first line of support for users, manages incidents, service requests, and changes, coordinates with internal Regulatory Application Analyst / Specialist, Internal IT Teams, and Vendor (like Veeva) for issue escalation, and plays a critical role in maintaining system stability and user satisfaction. Basic Veeva system configuration and reporting skills are essential.

KEY PERFORMANCE AREAS:

Application Support and Troubleshooting

• Provide 1st and 2nd line support for users of the Regulatory applications, E.g. Registrations, Submissions, Archive, CRM, and Safety.
• Monitor support queues, investigate and resolve incidents, log service requests, and ensure timely follow-up and closure.
• Troubleshoot common issues such as 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)
• Ensure Problem Management is followed, and RCA is provided for major & recurring incidents
• Follow GxP & CSV methods and ensure the system stays in a validated state with no deviations.

User Access Management

• Manage user onboarding/offboarding, access rights, and role-based permissions in compliance with internal SOPs.
• Assist with system audits of user access and role reviews to ensure regulatory compliance.

Incident Management & Escalation

• Collaborate with other team members, management, and service providers to escalate and resolve complex technical issues.
• Track and manage open issues using ticketing tools (e.g., ServiceNow), ensuring timely updates and user communication.

System Monitoring & Maintenance

• Perform daily health checks and monitor system performance to ensure uptime and data integrity.
• Track usage metrics, system logs, and user behaviour to proactively identify potential issues.

Documentation & Training

• Maintain system support documentation, including troubleshooting guides, FAQ articles, and job aids.
• Assist in user training sessions and creation of quick reference materials to improve adoption and reduce support requests.

Release Readiness & Testing

• Review release notes (E.g. Veeva Release notes) and assist in testing new features and updates.
• Support quarterly releases by validating critical functionality and reporting potential issues before go-live.

Continuous Improvements

• Collect feedback from end-users to identify pain points and suggest system enhancements.
• Participate in projects related to system upgrades, enhancements, or integrations (e.g., with Argus, ERP, or EDMS systems).

Requirements

• Bachelor’s degree in computer science, Information Technology, 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 one or more of the following highly desirable: 
• eQMS platforms (Veeva QMS)
• 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. 
• 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.