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 organization. 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.
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 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.
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.
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