Stefanie Becker
Senior GxP Expertin, Teamleiterin, Prokuristin at DiQualis Deutschland GmbH- Claim this Profile
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Englisch -
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Bio
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Credentials
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DGQ-Umweltmanagementbeauftragte
Deutsche Gesellschaft für Qualität (DGQ)Mar, 2021- Sep, 2024
Experience
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Senior GxP Expertin, Teamleiterin, Prokuristin
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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
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ISOmehr GmbH
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Germany
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Chemical Manufacturing
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Senior GxP Consultant, Teamleiterin
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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
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isomehr GmbH
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Germany
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Chemical Manufacturing
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Geschäftsführerin
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Dec 2017 - Mar 2018
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Pharmacelsus GmbH
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Germany
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Medical Practices
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Quality Manager & Marketing Manager
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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
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Business Development Manager
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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.
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ItN Nanovation AG
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Germany
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Mechanical Or Industrial Engineering
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1 - 100 Employee
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Product Manager
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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.
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Education
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Universität des Saarlandes
Dr. rer. nat., Chemie -
Universität des Saarlandes
Diplom, Chemie