Roles: Deviation & CAPA

Owns one or more corrective or preventive actions as defined in the IT CAPA plan and is accountable for successful implementation within agreed timelines. Documents implementation evidence in the deviation record in cooperation with the Deviation Owner.

Accountable for the strategic governance and oversight of the end-to-end deviation lifecycle, including design and maintenance of the Deviation/CAPA process, KPI monitoring, regular SOP reviews, and acting as the control owner for deviation-related risks. Serves as the escalation point for High Risk

Responsible for overall management of a deviation throughout its lifecycle, including leading impact assessment, classification, investigation, root cause analysis, and ensuring all corrective and preventive actions are implemented and verified. Assigned to the System Owner for system-specific devia