Job Description

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...

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