Major Responsibilities
Oversee the computerized system life cycle and ensure compliance with GxP standards and established procedures. Develop and maintain Computer System Validation (CSV) plans in alignment with 21 CFR Part 11 requirements. Manage deviations, change controls, investigations, and CAPA protocols. Author CSV protocols and related documentation. Review and approve documents before and after execution.
Job Qualifications / Minimum Requirements
At least 3 years CSV exp and 1-year exp with Emerson DeltaV hardware/software system