Dr. Michaela Brosig

Angestellt, Quality Systems and Data Specialist, Janssen Vaccines
Bern, Switzerland

Fähigkeiten und Kenntnisse

Quality Assurance
Team leadership
Clinical Trials
Management
GxP
GAMP5
CSV (Computer Systems Validation)
Project Quality Management
clinical investigator course
Quality Management
Account Management
ICE Silver (Project Management)
SOX
Test Management
Clinical Trial Documentation

Werdegang

Berufserfahrung von Michaela Brosig

  • Current 7 years and 4 months, since Feb 2019

    Quality Systems and Data Specialist

    Janssen Vaccines

  • 2 years and 6 months, Aug 2016 - Jan 2019

    Quality Documentation Specialist

    Janssen Vaccines AG

  • 5 years and 6 months, Feb 2011 - Jul 2016

    Consulting Manager

    Texelia (former cgi Switzerland )

    Computer System Validation, Project Quality Manager, Team Manager

  • 1 year and 2 months, Dec 2009 - Jan 2011

    Postdoc

    Department Biomedizin, Uni Basel

    Cardiovascular research

  • 3 months, Sep 2009 - Nov 2009

    Postdoc

    FMI

  • 4 years and 7 months, Jan 2005 - Jul 2009

    PhD student

    FMI

    Mechanotransduction, Muscular dystrophies

  • 4 months, Sep 2004 - Dec 2004

    Intern

    ATG biosynthetics

    building up a database for biotechnological products

  • 5 months, Aug 2002 - Dec 2002

    trainee

    Ontario Cancer Institute

    Department of Biophysics: X-ray crystallography of soluable and trans-membrane proteins

Ausbildung von Michaela Brosig

  • 2 years and 2 months, Feb 2012 - Mar 2014

    Clinical Trial Practice and Management

    Universität Basel

    GCP, Drug Development, Statistics, Regulatory Requirements, Bioethics, Clinical Study Planning, Quality Management, Patient Safety, Datamanagement, Reporting Standards, Communication Skills and Conflict Management

  • 4 years and 7 months, Jan 2005 - Jul 2009

    molecular biology

    Universität Basel/ Friedrich Miescher Institute for Biomedical Research (FMI)

    mechanotransduction in fibroblasts (PhD thesis), molecular biology, muscle cell development, mechanical stress, biomechanics, confocal microscopy, live-cell imaging

  • 5 months, Aug 2002 - Dec 2002

    biophysics

    University of Toronto

    X-ray crystallography

  • 3 years and 9 months, Oct 2000 - Jun 2004

    molecular biology

    Albert-Ludwigs-Universität Freiburg

    Screening for inhibitors of kinases PAK1, 2, and 4 in cancer development (diploma thesis), tumor biology, cell biology, immunology, biochemistry and bioinformatics

  • 2 years, Nov 1998 - Oct 2000

    Biology

    TU München

Sprachen

  • English

    C1 (Fließend)

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • French

    B1-B2 (Gute Kenntnisse)

  • Swedish

    A1-A2 (Grundkenntnisse)

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