Dr. Ulrike Burget

Inhaberin, GxP-Consultant, Quality Manager, QMConsult GxP-Services GmbH

München, Germany

Skills

Analyse und Verbesserung von GxP Prozessen
Abweichung- und CAPA-Management
Material und Lieferantenqualifizierung
Compliance Management
Schnittstellenproblematik in GxP-geregelten Bereic
Schlanke Qualitätssysteme
Optimierung der Dokumentation - Berichte
Risikobewertung
Audit-Services (Lieferantenaudits - Mock Audits -
Inspektionsvor- und Nachbereitung
FDA-Erfahrung
20+ Jahre Erfahrung als Quality Manager - Auditor

Timeline

Professional experience for Ulrike Burget

  • Current 7 years and 11 months, since Feb 2017

    GxP-Consultant, Quality Manager

    QMConsult GxP-Services GmbH

    GxP quality management (especially GMP, GLP, GCLP, GDP), Process analysis and improvement, Compliance management. Material and supplier qualification, Deviation/Investigation/CAPA management, Change management, Risk assessment, Inspection pre- and postprocessing.

  • 2012 - 2017

    GxP Consultant, Quality Manager, Auditor

    QMConsult GxP- and Audit-Services

    Interim Quality Management, Process analysis and improvement, Compliance management, Audits and Self-inspections. Material and supplier qualification, Quality management in laboratories, Deviation/Investigation/CAPA management, GMP in Development, Quality management/Wolesaler.

  • 2011 - 2015

    Senior Lead Auditor

    SQA Services, Inc.

    Supplier audits (DS, API, excipients, medical devices, wholesale/distribution, laboratories), preparation of custom audit reports.

  • 2001 - 2011

    Head of Quality Assurance

    BioProof AG

  • 1996 - 2001

    Quality Assurance Representative

    Klinge Pharma GmbH

  • 1991 - 1995

    Head of Quality Assurance

    ANAWA München AG

  • 1986 - 1990

    Regulatory Affairs Expert

    ESPE GmbH & Co. KG

Educational background for Ulrike Burget

  • Chemie

    Ludwig-Maximilians-Universität München

Languages

  • German

    -

  • English

    -

Interests

GxP
GLP
GCLP
GMP
GCP

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