Since I work I was in contact with health industries such as: clinical trials, pharmaceutical development, medical devices, and telemedicine computerized systems.
Through the missions I performed as temporary worker and consulting staff, I improved my know-how of those industries and related regulations: GCP, GMP, ISO 13485, CE mark, 21CFR-11.
49 contacts
Aurore Michard
Quality Engineer - Biotechnology
Tresserve - France
| English | French |
Schools attended |
Since 2006: Small Company (Medical Device) |
Quality Manager
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Implementation of the Quality Management System (ISO 13485:2003) Set up of the CE technical file (directive 93/42/CEE) It distributes hyaluronic acid used for wrinkles implants. | |
Sector: Biotech |
2006 : Galderma - Industrial Development |
Quality Engineer
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Follow-up of deviations and derogations Audit of formulation, batch and study files Follow-up of quality documents Temporary work (5 months) http://www.galderma.com Galderma manages dermatologic products making (pharmaceutical and cosmetic use). The development site is in charge of formula/processes improvement. It also produces batches for clinical trials. | |
Sector: Health and pharmaceutical |
2006 : Independant Consulting |
Independant Quality Engineer
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One-off work on quality mission for independent consulting: -set in compliance to ISO 9001:2000, staff training -help to set-up ISO 13485:2004 and CE technical file | |
Sector: Consulting and Services |
2005 : StemCell Technologies France |
Quality Manager
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Regulatory assessment Set-up of Quality Management System (ISO 13485:2003) Preparation for CE marking (98/79/CE directive) Temporary work (8 months) http://www.stemcell.com STF distribute cell separation media and reagents. The site located in Grenoble is the French antenna of the production site in Vancouver, CA (100-200 staff member) | |
Sector: Health and pharmaceutical |
2002 - 2005 : MDS Pharma Services Central Lab |
Quality Assurance Associate
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Main activities: -regulatory training (ICH-GCP, 21-CFR 11) -internal audits, -coordination of clients visits -documents management -follow-up of CAPA -help to internal sector (validation, accreditation, study set-up) -global harmonization with sites in Toronto and Hamburg study of GBEA and ISO 17025 for the harmonization activity Permanent work http://www.mdsps.com MDS PS Central Lab works as a lab for pharmaceuticals industry in clinical study context (biology analyses, telemedicine) | |
Sector: Health and pharmaceutical |
2002 : MDS Pharma Services Central Lab |
Quality Assurance Coordinator
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Engineer training period in quality assurance dpt (8 months) During that period I was in charge of the lab accreditation renewal, which was passed with success. http://www.mdsps.com MDS PS Central Lab works as a lab for pharmaceuticals industry in clinical study context (biology analyses, telemedicine). | |
Sector: Health and pharmaceutical |
2001 : MDS Pharma Services Central Lab |
Validation Assistant
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On-study training period in Telemedicine dpt (6 months) During that period I was in charge of creating the first validation file for a computerized system used in Telemedicine according to 21-CFR part 11 (IQ, OQ, PQ, protocol and reports). http://www.mdsps.com MDS PS Central Lab works as a lab for pharmaceuticals industry in clinical study context (biology analyses, telemedicine). | |
Sector: Health and pharmaceutical |
Hobbies |
2-years world travel in sailing boat (1990-1992) Journey in Kenya Horse riding, hiking, reading |