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Isabelle Giraud

Pharm D, Project leader in pharmaceutical development

Chartres - France

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Pharm D with a master degree, I work for Ethypharm, a DDS leader. I am in charge of internal and clients projects for parts concerning scale-upping and process validation

Since June 2006, I lead an association, the Bordeaux Rotaract Club and I ride horses (jumping).

Schools attended

Université Bordeaux 2 Victor Segalen (UFR Sciences Pharmaceutiques)
Université Tours Francois Rabelais (UFR Sciences Pharmaceutiques)

Since 2008: Ethypharm

Project leader Process development
Organization of Process scale-up, transfert and opimization:
- Projects planning and determination of human and material needs
- Writing of process development and validation protocoles/reports
- Determination of clients conditions
- Planning and animation of projects meetings
- Collecting of technical documents
- Writing of CTD parts which concern manufacturing process and its development
- Close cooperation with QA department, analytical department, regulatory affairs medical affairs…
- Inter-plants transferts
- Technological up-dating
Sector: Health and pharmaceutical

2005 - 2008 : PHYSICA Pharma

Project leader Formulation development
Galenical feasibility and development (tablets, capsules, pastes, injectables for human or veterinary use): pre-formulation, formulation, trials and studies planning, raw materials sourcing (excipients and APIs), contract manufacturer finding, scale-up, technological up-dating

Analytical development (HPLC, UV): in close cooperation with the analytical service of the society, development and validation of analytical methods for APIs and finished products

Regulatory affairs: CTD Module 3 writing (in English), regulatory up-dating
Sector: Health and pharmaceutical

Interests

Rotaract, horseback riding

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