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Technical Validation Business Systems Analyst
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- Create and maintain validation documentation, such as Validation Plans, User Requirements Specifications (URS), Traceability Matrix, and Validation Summary Reports Participate in change control processes and ensure compliance with regulatory requirements.
- Authors IT validation documents for hardware and software, manages document review and approval workflows.
- Experience gathering business requirements, software testing (UAT, IQOQ), creating and writing SOP's and GXP validation documentation (includes but not limited to User Requirements Specs, System Design Documents, IT System Administration Guides) Interface and liaise between IT, Business (all levels of lab staff and management) as well as Third Party vendors.
- Understanding of data management for GxP systems Implementing and managing data integrity across lab and enterprise systems Data resiliency – backup, restore, archive Audit trails.
- Performing annual account reviews, periodic reviews Performing GMP data quality assessments and managing deviations Managing document review and approval workflows in a global document management system Working with data archiving and electronic document management systems (in house systems are OpenLab and Veeva Quality Docs) Manage IQOQ and UAT – write and execute test scripts, author test summary reports.
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