Ensure GLP, GCP, GVP and GRA business systems are fully compliant with regulatory expectations (e.g. OECD, ICH, GVP) and internal digital governance requirements. * 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. * Solid knowledge of GLP, GCP, GVP and GRA regulatory frameworks and associated expectations for computerized systems (e.g., OECD GLP, ICH E6(R3), EU GVP Module I/IX).
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