Anika Thewis

Angestellt, Quality Control Manager, Carl Zeiss Meditech AG
Berlin, Germany

Fähigkeiten und Kenntnisse

Quality management
ISO 13485
Medical Devices
Training Management
Change Management
Supplier Management
Internal Audit
Post Market Surveillance
MDD
Clinical diagnostics
GMP
Biotechnology
Training
Prozesse
QMS
Creativity
Team Spirit
Team leadership
Qualitätskontrolle
Medical Device Regulation (MDR)
FMEA
Reinraum

Werdegang

Berufserfahrung von Anika Thewis

  • Current 2 years, since Jun 2024

    Quality Control Manager

    Carl Zeiss Meditech AG

    - teamlead - cleanroom qualification - equipment qualification - final control, final release - non conforming products

  • 2 years and 11 months, Jul 2021 - May 2024

    Quality Referent

    Carl Zeiss Meditec AG

    - ISO 13485, MDR, MDSAP - Change control - internal Audits - external Audit coordinator - Management review - Risk Manager - Document Control

  • 3 years and 7 months, Dec 2017 - Jun 2021

    Quality Manager

    Vanguard AG

    - Training- and change management - Supplier qualification - Post market surveillance - Internal audits

  • 8 months, Apr 2017 - Nov 2017

    Masterthesis

    Rheumatological research laboratory, Charité Berlin

    FACS analysis, cellculture, determination of global DNA methylation

  • 5 months, Oct 2016 - Feb 2017

    Internship

    Drägerwerk AG & Co. KGaA

    - Development of a lateral flow immunoassay - Optimization of existing drug testing systems

  • 11 months, Nov 2015 - Sep 2016

    Study assistant

    emovis GmbH

    - Organization within clinical studies - Contact with patients and coordinators

  • 3 years, Oct 2012 - Sep 2015

    Cooperative study programme

    Thermo Fisher Scientific B∙R∙A∙H∙M∙S GmbH

    - Quality assurance, statistical interpretation of data for precision profiles - Change Control processes - Development of immunological test systems, protein purification

Ausbildung von Anika Thewis

  • 2 years and 5 months, Oct 2015 - Feb 2018

    Biotechnology

    Beuth University of Applied Sciences Berlin

    Molecular medicine and biology, cell biology, tissue engineering, protein biotechnology, molecular pharmacology, immunology, bioprocessengineering, industrial biotechnology, biostatistics

  • 3 years, Oct 2012 - Sep 2015

    Biotechnology

    University of Cooperative Education Riesa

    Fundamentals of process engineering, instrumental analysis, measuring and sensor technology, project and business management, quality management, cell biology, microbiology methods, genetics, biochemistry, enzyme technology, bioreaction technology , cell culture technology

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • French

    A1-A2 (Grundkenntnisse)

  • Spanish

    A1-A2 (Grundkenntnisse)

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