Group Analyst: Regulatory and Quality Applications

Aspen Holdings

KPA:

System Administration & Configuration
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.
Technical lead system upgrade s/releases as per Vendor quarterly release cycles.
Work on minor enhancement/backlog initiatives for regulatory applications, i.e. building of custom report, deployment of Sing-Sign-on or a new security policy.
Conduct routine system checks, maintenance tasks, and support validated state upkeep.
Regulatory & Quality Support
Ensure systems are available and functioning for Quality and Regulatory processes (e.g., submissions, CAPAs, audits, deviations, SOPs, training).
Support data integrity controls including audit trails, electronic signatures, and controlled documents.
Assist in execution of controlled changes following QA-approved processes.

Compliance, Validation & Documentation
Maintain validation documentation including URS, IQ/OQ/PQ, change controls, and risk assessments.
Support internal/external audits, inspections, and regulatory reviews.
Ensure system documentation, SOPs, user guides, and training material remain updated.
Issue Resolution & User Support
Provide Tier 2 and 3 support for application issues, escalating to Manager, vendors, or IT infrastructure where required.
Troubleshoot workflow failures, configuration errors, access issues, and data inconsistencies.
Ensure timely resolution of incidents in line with SLAs. Training & Change Management
Develop and deliver user training, onboarding materials, and system guides.
Communicate system updates, enhancements, and release impacts to end users.
Promote consistent global usage of Regulatory & Quality systems.
Vendor & Stakeholder Coordination
Coordinate with vendors for issue resolution, small changes, or enhancement support.
Participate in requirements gathering and solution assessments.
Track software licences, renewals, and small system contracts (supporting the Manager, not owning).
Data Governance & Reporting
Ensure accuracy, consistency, and integrity of data across Regulatory & Quality systems.
Generate reports, dashboards, metrics, and compliance indicators.
Support analyses for audits, regulatory submissions, and management reviews.
Service Delivery & Monitoring
Monitor system performance, availability, and incident trends.
Contribute to continuous improvement initiatives to enhance system reliability.
Support proactive identification of risks and potential issues.