CAPA Compliance Manager Job at SGS Consulting, Delaware, OH

  • SGS Consulting
  • Delaware, OH

Job Description

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              

Job Tags

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