Stefanie Becker

Senior GxP Expertin, Teamleiterin, Prokuristin at DiQualis Deutschland GmbH
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Location
Saarland, DE
Languages
  • Englisch -

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Credentials

  • DGQ-Umweltmanagementbeauftragte
    Deutsche Gesellschaft für Qualität (DGQ)
    Mar, 2021
    - Sep, 2024

Experience

    • Senior GxP Expertin, Teamleiterin, Prokuristin
      • Apr 2021 - Present

      Standortleitung Saarbrücken (Business Units ISO + GLP), Teamleitung GLP (externe Qualitätssicherung), Beratung GxP, Ansprechpartner für GCLP, Akkreditierung ISO 17025, 15189, CSV, Geräte-Qualifizierung, LIMS, Data Integrity, Beratung beim Aufbau von Qualitätsmanagementsystemen, Durchführung von Gap-Analysen, Durchführung von externen Audits im Kundenauftrag, Begleitung von Kundenaudits und Behördeninspektionen, Durchführung von Schulungen Standortleitung Saarbrücken (Business Units ISO + GLP), Teamleitung GLP (externe Qualitätssicherung), Beratung GxP, Ansprechpartner für GCLP, Akkreditierung ISO 17025, 15189, CSV, Geräte-Qualifizierung, LIMS, Data Integrity, Beratung beim Aufbau von Qualitätsmanagementsystemen, Durchführung von Gap-Analysen, Durchführung von externen Audits im Kundenauftrag, Begleitung von Kundenaudits und Behördeninspektionen, Durchführung von Schulungen

    • Germany
    • Chemical Manufacturing
    • Senior GxP Consultant, Teamleiterin
      • May 2018 - Mar 2021

      Quality management • Performance of study-based and facility-based inspections/audits / document management / supervision of test equipment monitoring and validation / communication with authorities / support of external inspectors/auditors from clients and authorities / performance of internal trainings for GLP/GCLP Quality management • Performance of study-based and facility-based inspections/audits / document management / supervision of test equipment monitoring and validation / communication with authorities / support of external inspectors/auditors from clients and authorities / performance of internal trainings for GLP/GCLP

    • Germany
    • Chemical Manufacturing
    • Geschäftsführerin
      • Dec 2017 - Mar 2018
    • Germany
    • Medical Practices
    • Quality Manager & Marketing Manager
      • Jan 2013 - Nov 2017

      Quality Manager in a GLP/GCLP laboratory, responsible for: internal audits and inspections, inspections of GLP studies, study plans and study reports, maintenance of the GLP statusMarketing Manager as part of the sales & marketing department, responsible e.g. for public relations

    • Business Development Manager
      • Mar 2009 - Dec 2012

      As Business Development Manager responsible for sales & marketing, opening of new markets, maintenance of customer contact, visiting business fairs, acquisition of new customers, marketing projects, expert instruction for the employees etc.

    • Germany
    • Mechanical Or Industrial Engineering
    • 1 - 100 Employee
    • Product Manager
      • Jan 2006 - Jan 2009

      As Product Manager responsible for three product groups, essential link between the sales team and scientists, responsible for market analysis, the manufacturing process as well as the technical documentations for the sales team, public relations and marketing of the products. As Product Manager responsible for three product groups, essential link between the sales team and scientists, responsible for market analysis, the manufacturing process as well as the technical documentations for the sales team, public relations and marketing of the products.

Education

  • Universität des Saarlandes
    Dr. rer. nat., Chemie
    2001 - 2004
  • Universität des Saarlandes
    Diplom, Chemie
    1994 - 2001

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