CAPA Compliance Manager
SGS Consulting
Job Responsibilities:
- 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, and 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
Skills:
- 5 years of at least CAPA experience in medical device
Education/Experience:
- Bachelor’s degree required
Vacancy posted more than 2 months ago
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