Group Analyst: Regulatory and Quality Applications
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Key skills for this role
About the Role
Responsible for administration and support of regulatory and quality systems, ensuring compliance, data integrity, and user training while managing system configurations.
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
- Configure workflows, rules, fields, and metadata according to approved designs
- Lead system upgrades/releases as per Vendor quarterly release cycles
- Conduct routine system checks, maintenance tasks, and support validated state upkeep
- Provide Tier 2 and 3 support for application issues
- 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
Requirements
- Experience in administration and configuration of regulatory/quality systems (eQMS, RIMS, DMS, Audit platforms)
- Knowledge of GxP, 21 CFR Part 11, ISO 9001, ISO 13485
- Experience with validation documentation (URS, IQ/OQ/PQ, change controls, risk assessments)
- Strong troubleshooting and problem solving skills
- Ability to develop and deliver user training
Full Job Posting
Role Overview
- 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.
Key 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.
- 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 custom report, deployment of Single Sign On or a new security policy.
- Conduct routine system checks, maintenance tasks, and support validated state upkeep.
- 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.
- 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.
Qualifications and Experience
- Experience in administration and configuration of regulatory/quality systems (eQMS, RIMS, DMS, Audit platforms).
- Knowledge of GxP, 21 CFR Part 11, ISO 9001, ISO 13485.
- Experience with validation documentation (URS, IQ/OQ/PQ, change controls, risk assessments).
- Strong troubleshooting and problem solving skills.
- Ability to develop and deliver user training.
Skills
- Proficiency in eQMS, RIMS, Document Management Systems, Audit Platforms.
- Understanding of regulatory standards: GxP, 21 CFR Part 11, ISO 9001, ISO 13485.
- Validation documentation and change control processes.
- User training and support.
- Vendor coordination and incident management.
Additional Information
- 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.
- 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).
- 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.
- 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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