Ing. Dafne De Gottardi
Fähigkeiten und Kenntnisse
Werdegang
Berufserfahrung von Dafne De Gottardi
Computer System Validation Consultant (CSV) for Food and Pharmaceutical Industries. Write and execute CSV documents and Protocols in compliance with: EU GMP Vol 4 Annex 15 Qualification and Validation and Annex 11 Computerized Systems GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems FDA 21 CFR Part 210 cGMP general FDA 21 CFR Part 211 cGMP for finished pharmaceuticals FDA 21 CFR part 11 Electronic records & signatures WHO Annex 5 Guidance on good Data and Record Management
- 5 months, Jul 2017 - Nov 2017
Quality Engineer - Contractor: Production Risk Management
DePuy Synthes
- Review and Process approval of Production Risk Management Documents in compliance with ISO 14971:2012 - Medical devices - Application of risk management to medical devices. - Teamwork in English/German and Italian languages. - Good Knowledge of GDP - Teamwork with Quality Engineer
- 10 months, Sep 2016 - Jun 2017
Manufacturing Engineer: Manufacturing Process Information Coordinator
DePuy Synthes
Support Manufacturing Engineer to complete Manufacturing Process Information Documents in compliance with ISO 13485:2016 Medical devices - Quality management systems - Teamwork in English/German and Italian languages. - Good Knowledge of GDP - Teamwork with Manufacturing Engineer and Supplier Quality Engineer - Monitoring of weekly Report - team effort with SAP ERP, Agile PLM System and Windchill PLM System
- 2 years, Jan 2015 - Dec 2016
Manufacturing Engineer: Production Risk Management Consultant
DePuy Synthes
- Support Manufacturing Engineer to complete Production Risk Management Documents in compliance with ISO 14971:2012 - Medical devices - Application of risk management to medical devices. - Create and Management of Manufacturing Process Information in compliance with ISO 13485:2016 Medical devices - Quality management systems - Teamwork in English/German and Italian languages. - Good Knowledge of GDP - Teamwork with Quality Engineer
- 4 months, Sep 2014 - Dec 2014
Computer System Validation - Consultant
Adeodata SA / DePuy Synthes
Technical writer
Ausbildung von Dafne De Gottardi
- 2010 - 2014
Technology and Innovation Management
Scuola universitaria professionale della Svizzera italiana (SUPSI)
Pharmaceutical: Design, realization and management of laboratories and installation, supply chain management
Sprachen
Italian
C2 (Verhandlungssicher / Muttersprachlich)
English
C1 (Fließend)
German
B1-B2 (Gute Kenntnisse)
French
A1-A2 (Grundkenntnisse)
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