Group Analyst: Regulatory and Quality Applications
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Key skills for this role
About the Role
Operational role within the Group Digital Technology team responsible for the administration, configuration, and support of systems used for regulatory, quality, and compliance.
Key Skills for This Role
Responsibilities
- Perform day to day administration and configuration of Regulatory & Quality systems (eQMS, RIMS, DMS, Audit platforms)
- Manage user accounts, roles, permissions, and security groups
- Conduct routine system checks, maintenance tasks, and support validated state upkeep
- Provide Tier 2 and 3 support for application issues, escalating to Manager, vendors, or IT infrastructure where required
- Maintain validation documentation including URS, IQ/OQ/PQ, change controls, and risk assessments
- Support internal/external audits, inspections, and regulatory reviews
- Develop and deliver user training, onboarding materials, and system guides
- Coordinate with vendors for issue resolution, small changes, or enhancement support
- Generate reports, dashboards, metrics, and compliance indicators
- Monitor system performance, availability, and incident trends
Requirements
- Experience administering regulatory and quality systems (eQMS, RIMS, Document Control, Audit & Compliance)
- Knowledge of GxP, 21 CFR Part 11, ISO 9001, ISO 13485
- Experience with validation documentation (URS, IQ/OQ/PQ, change controls, risk assessments)
- Strong analytical and troubleshooting skills
- Ability to provide Tier 2 and 3 support
- Experience with user training and documentation
Full Job Posting
Job Overview
- Operational role within the Group Digital Technology team responsible for administration, configuration, and support of regulatory, quality, and compliance systems.
- Serves as application specialist for eQMS, RIMS, Document Control, Audit & Compliance systems, and other regulatory/quality tools.
- 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.
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.
- 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.
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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