CAPA Compliance Manager

Job Description

CAPA Review Board:

• Prepare material
• Generate data for charts (21 data sets / charts)
• Analyze trends
• Provide talking points
• Load minutes and attendance to Agile

KPI Meeting:

• Prepare material
• Generate data for charts (duplicates CRB except 2 NCE charts)
• Analyze trends
• Provide talking points

Process change orders for Corporate CAPA and NCE documents:

• Corporate CAPA and NCE procedures and work instructions.
• Agile-CAPA and Agile-NCE validation and specification documents.
• Administrative files for Agile-CAPA and Agile-NCE (e.g., dropdown lists).
• Facilitating CAPAs and NCEs.
• Preparing and distributing quarterly Overdue CAPA/IACA report.
• Preparing and distributing monthly CAPA Aging report to QLT.
• Review and approving Agile access requests – CAPA, NCE.
• Periodic review of open COR, CAPA, and NCEs (globally).
• Validate and test Agile-CAPA and Agile-NCE tool changes.
• Author validation/specification documents for Agile-CAPA and Agile-NCE (e.g., SRS, SDD).
• Maintain CAPA/NCE SharePoint page.
• Collaborate with AI team to establish AI proof of concept for identifying potential compliance issues in CAPAs.
• Ad hoc data analysis.