Vacancy Description
Responsibilities
- Partner cross-functionally with IT and the business to implement and maintain compliant computerized systems
- Provide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards
- Serve as the QA CSV SME during vendor evaluations, software implementation and qualification and requalification of GxP systems
- Support continuous improvement of GxP Systems through SOP development, training, and change control management
- Lead investigations for CSV-related deviations, system failures, and data integrity issues
- Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports
- Perform internal audits to ensure systems are maintained in a steady state
- Support validation and QA oversight of AI/ML-enabled GxP systems
Requirements
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