Collaborate with other and business stakeholders to define validation requirements, risk-based controls, and deliverables for external systems that generate or process GxP data. * Assess and document Data Integrity risks associated with externally operated systems and the interfaces linking them to internal systems, ensuring that controls are in place to protect data reliability, and traceability. * Strong understanding of Computerized System Validation (CSV) principles, including risk-based approaches and system lifecycle activities. * Ability to assess external vendor systems for compliance, validation status, and DI risk, including interpretation of validation packages and supplier documentation. * Ability to interpret complex data flows across external and internal systems and identify data integrity risks across the full lifecycle.
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