Overview
Group Analyst: Regulatory & Quality Jobs in Durban, South Africa at Aspen Pharma Group
Position: Group Analyst: Regulatory & Quality Applications
JOB PURPOSE:
Operational role within the Group Digital Technology team responsible for the administration, configuration, and support of systems used for regulatory, quality, and compliance operations across the organisation. The Group Analyst serves as an application specialist supporting enterprise platforms such as eQMS, RIMS, Document Control, Audit & Compliance systems, and other regulatory/quality tools. The role ensures systems are maintained in a validated state, operated securely, and aligned with global regulatory standards including GxP, 21 CFR Part 11, ISO 9001, and ISO 13485.
The incumbent supports the Regulatory and Quality teams with reliable system access, troubleshooting, training, documentation, and coordination of system changes, while working with IT, vendors, and auditors to maintain data integrity, compliance, and continuous improvement.
KEY PERFORMANCE AREAS:
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 upgrades/releases as per Vendor quarterly release cycles.
• Work on minor enhancement/backlog initiatives for regulatory applications, i.e., building of a 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 the 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 the 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.
Title: Group Analyst: Regulatory & Quality
Company: Aspen Pharma Group
Location: Durban, South Africa
Category: