Group Analyst: Regulatory and Quality Applications
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Key skills for this role
About the Role
Aspen Holdings is seeking a Group Analyst to administer, configure, and support regulatory and quality applications like eQMS, RIMS, and Document Control. The role ensures systems are validated, secure, and compliant with GxP, 21 CFR Part 11, ISO 9001, and ISO 13485.
Key Skills for This Role
Responsibilities
- Administer, configure, and support regulatory and quality applications such as eQMS, RIMS, Document Control, and Audit & Compliance systems
- Ensure systems are maintained in a validated state and aligned with global regulatory standards
- Provide reliable system access, troubleshooting, training, and documentation
- Coordinate system changes with IT, vendors, and auditors to maintain data integrity and compliance
Requirements
- Experience in administration, configuration, and support of regulatory/quality systems
- Knowledge of GxP, 21 CFR Part 11, ISO 9001, ISO 13485
- Ability to work with IT, vendors, and auditors
Full Job Posting
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.
Key Responsibilities
- Support the 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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