Support investigations, deviations, CAPAs, and inspection-readiness activities related to DI or system failures, ensuring completeness and alignment with regulatory expectations. * Ensure appropriate documentation (URS, validation packages, data flows) is in place for external systems supporting clinical studies and activities. * Strong understanding of Computerized System Validation (CSV) principles, including risk-based approaches and system lifecycle activities. * Experience in managing deviations, investigations, and CAPA activities within at least one GxP domain.
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