Jasminka Roth
Vorstandsmitglied, Founder and Director, The Tao of Excellence
Beringen, Schweiz
Werdegang
Berufserfahrung von Jasminka Roth
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 Jahre und 6 Monate, Dez. 2010 - Mai 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
- 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'.
Ausbildung von 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.
Sprachen
Deutsch
Muttersprache
Englisch
Fließend
Französisch
Gut
Croatian
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