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Responsibilities:
Provide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards
Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports
Lead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysis
Partner cross-functionally with IT, Engineering, Automation, and Operations to implement and maintain compliant computerized systems
Support continuous improvement of site Quality Systems through SOP development, training, coaching, and change control management
What You Need to Succeed (minimum qualifications):
Education: Bachelor’s Degree in Science, Technology, Engineering, Computer Science, or a related technical discipline (or equivalent experience...