QA CSV Engineer (m/f/d)

Jobdescription Key Responsibilities · Contribute to CSV strategies, plans, and protocols in accordance with regulatory As a QA IT CSV Engineer, you will be responsible for ensuring compliance for computerized systems and computerized systems validation, fulfill with regulatory requirements and operate as intended. Your primary responsibilities will include:guidelines (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5) · Contribute to risk assessments and participate to test scripts for computer system validation activities · Supervise validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) · Document validation activities, findings, deviations and CAPA in compliance with regulatory requirements · Conduct reviews

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