Sr. Process and Systems Optimization Specialist - Rio de Janeiro, Brasil - Thermo Fisher Scientific

Ana Silva

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Ana Silva

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Descrição
Review, monitor and approval of controlled process documents for quality, compliance, and commitment gaps, in co-ordination with Sub Process Owners (SPOs) or Process Owners (POs) - Compliance Support - Review, assess, monitor and approve process deviations - Lead investigation and assist in Root Cause Analysis of Quality Issues (QI) and CAPA - Review and approve QualityIssues (QI) - Assist the CAPA owner in performing Root Cause Investigations, review and approve CAPA actions - Monitor CAPA to completion - Audits and Inspections

  • Pre-Inspection Support


  • Inspection Readiness Training

  • Mock Interview sessions
  • Pre-Inspection Doc request and review
  • During Inspection support


  • Cohost/Host

  • Inspection Doc Request support
  • Control Room support
  • Post-Inspection Support
  • Lead CAPA plan completion
  • CAPA Monitoring to Completion
  • Ensure R&D Quality Management System maintenance in the Affiliate Medical Teams

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