Testing Strategy & Quality Oversight: Define and review test strategies, test plans, and test reports in collaboration with product owners and technical teams. Provide consultancy on test-related deviations, corrective actions, and preventive measures
Change Control & System Maintenance: Assess the validation impact of system changes, enhancements, and patches – ensuring that the validated state is preserved across all system updates and that change control processes are followed in accordance with Roche SOPs
Deviation & CAPA Management: Support deviation investigations to identify root causes and define corrective and preventive actions (CAPAs), ensuring timely closure and regulatory compliance
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