Basic

Jasminka Roth

Vorstandsmitglied, Founder and Director, The Tao of Excellence

Beringen, Schweiz

Skills

Proven track record in establishing and maintaining a quality system within the medical device environment (50 + audits). Longterm experience as a leader for the quality management and business excell
strong technical background
interdisciplinary thinking
positive personality
ISO 9001:2015
ISO 9001:2008 und Anpassung an :2015
Medical Device Single Audit Program (MDSAP)
Consulting

Timeline

Professional experience for Jasminka Roth

  • Current , since Jun 2015

    Founder and Director

    The Tao of Excellence

    We provide applied expertise in manufacturing and management processes throughout the pharma, combination products, medical device and health care industry. Our in-depth understanding of the normative requirements combined with a potent business excellence tool set enables us to provide a tailor-made service for a commercially sustainable quality design.

  • 4 years and 6 months, Dec 2010 - May 2015

    Quality Management Representative

    Alhenia AG

    - Head of Quality Department: organisational and operational lead including the metallographic lab for coating characterization - Design, implementation and maintenance of quality system (according to ISO 13485, 21 CFR part 820)
- Lead for all audit activities: customers, Notified Bodies, suppliers, internal audits (>50 audits) - Lead for project kick-off in EU Project 'COATIM' (Framework 7) - Lead for regulatory affairs: Submission of 3 medical coatings with FDA and for customer regulatory support

  • 7 years and 3 months, Aug 2003 - Oct 2010

    Senior Scientist

    Johnson & Johnson

    - Lead of lean set up of medical device lab incl. all systems for complaint management
- Technical lead of up-scaling, transfer and validation of assembly process and analytical methods for combination products at Cilag and at CMO
- Lead of technical transfer projects for aseptic fill finish activities for at Cilag AG and at CMO - Lead of root cause investigation projects for failure analysis within the SmartJect Autoinjector platform. Including process excellence studies such as Design of Experiment (DOE)

  • 2002 - 2003

    Research Scientist

    Inselspital, Universitätsspital Bern

    Scientific focus: cell signalling in cancer cells and in mouse models: 
 - Setup of analytical laboratory with bio-chemical, molecular biological and histological profile
 - Planning, drafting for licence and execution of clinical studies in mouse models
 - Supervision of master level research projects

  • 2000 - 2001

    Master student

    Eidgenössische Technische Hochschule (ETH) Zürich

    Title: 'Cloning and expression of Beyer-Villiger Mono-oxygenases'.

  • 1999 - 1999

    Bachelor student

    University of Sydney

    Title: 'Cloning and expression of protein binding Zinc finger-domains'.

Educational background for Jasminka Roth

  • 2007 - 2007

    Business Excellence

    Johnson and Johnson

    Certification with successful project

  • 2006 - 2006

    Business Excellence

    Johnson and Johnson

    Certification with successful project

  • 2006 - 2007

    Project Management

    AKAD-Fachhochschulen

    Certification with successful project

  • 2004 - 2004

    Business Excellence

    Johnson and Johnson

    Certification with successful project

  • 1996 - 2001

    Biotechnology

    Eidgenössische Technische Hochschule Zürich

    Main subjects in Biotechnology and biochemistry: Bioengineering and genetic engineering.

Languages

  • German

    First language

  • English

    Fluent

  • French

    Intermediate

  • Croatian

    -

Interests

Yoga
Meditation
Stressmanagement
Travel

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