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CAPA Specialist -Medical Devices - Oferta z Jobs.pl

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  • Miejscowośćinne
  • AdresAustria,
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CAPA Specialist -Medical Devices

Nr ref.: /JOBS.pl

  • We are searching for a Quality Assurance Specialist with a focus on CAPA coordination, to join one of the most renowned global pharmaceutical, medical device and consumer health organisations at their base in Austria. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide.The CAPA Specialist will provide site-specific implementation and monitoring of standardized procedures, processes and systems to deliver consistent CAPAs compliant with standards and Medical Device RegulationsMain Duties:
    Support the implementation of the standardized procedures, processes and systems for CAPADeliver education and interactive training for CAPA users to deliver consistent compliant CAPAs including Failure Investigation, CAPA Review Board and CAPA contentAssist CAPA users with development and documentation of problem statements, containment and correction, root cause, and action plan (including effectiveness monitoring) determination.Maintain overall management and effectiveness of the CAPA system including the process and application for the site.Provide CAPA compliance metrics and weekly management tracking report.Implement measures to monitor the effectiveness of the CAPA system. Ensure results of verification and monitoring of the effectiveness of CAPA and its compliance to applicable regulations and standards of monitoring process are routinely communicated to management.
    Qualifications and Experience:
    Strong knowledge of quality and compliance for Medical Device Industry (GMPs).Expert knowledge of the US Quality System Regulations Demonstrated track record of delivering best in class results in the Quality Systems areaRisk Management, NCRProven ability to build partnerships both internally and externallyGerman: very good in spoken, good in written, English: fluent (spoken and written) is MUST
    If you are interested in applying, please send your CV to Beata Klecz on or call . A full job description is available on request.


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