Group Analyst: Regulatory and Quality Applications
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Key skills for this role
About the Role
Aspen Holdings seeks a Group Analyst for Regulatory and Quality Applications to support enterprise platforms like eQMS, RIMS, and Document Control. The role involves system administration, configuration, troubleshooting, and ensuring compliance with GxP and ISO standards.
Key Skills for This Role
Responsibilities
- Administer, configure, and support regulatory and quality systems
- Maintain systems in a validated state and ensure compliance with global regulatory standards
- Provide reliable system access, troubleshooting, training, and documentation
- Coordinate system changes with IT, vendors, and auditors
- Support data integrity and continuous improvement
Requirements
- Experience with regulatory and quality applications such as eQMS, RIMS, Document Control, Audit & Compliance systems
- Knowledge of GxP, 21 CFR Part 11, ISO 9001, ISO 13485
- System administration and configuration skills
- Troubleshooting and user support experience
- Strong documentation and communication skills
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.
Key Responsibilities
- Administer, configure, and support enterprise platforms such as eQMS, RIMS, Document Control, Audit & Compliance systems, and other regulatory/quality tools.
- Ensure 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.
- Support Regulatory and Quality teams with reliable system access, troubleshooting, training, documentation, and coordination of system changes.
- Work with IT, vendors, and auditors to maintain data integrity, compliance, and continuous improvement.
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