Systems Administrator, Electronic GxP Systems
Tasks
- Administer electronic GxP systems
- Configure system workflows and forms
- Develop and manage system level reports
- Ensure validated controlled system state
- Maintain electronic GxP system inventory
- Maintain inspection ready validation documentation
- Perform controlled system changes
- Provide system subject matter expert support
- Provide system validation planning and execution support
- Support internal audits and regulatory inspections
- Troubleshoot and resolve electronic GxP system issues
Perks/Benefits
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | ALCOA plus | Access Control | Audit management | CAPA | CFR Part 11 | Change Control | Data Integrity | Deviation Management | Document Control | Documentum | Electronic GxP | GxP | ICH Guidelines | IQ/OQ | IQ/OQ/PQ | ISO 13485 | Investigation management | MasterControl | Metadata taxonomy | Microsoft 365 | OQ PQ | Part 11 | Reporting | Risk-based | Risk-based validation | Security Models | System validation | Systems administration | TrackWise | Training Management | User Access Control | User access | Veeva
Education
Roles
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