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GlaxoSmithKline
- Product & Portfolio Quality Senior Specialist (Q4RD)
Marly-le-Roi
2016 - maintenant
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GlaxoSmithKline
- Product & Process Expert (Technical R&D, GMP Manufacturing & Supply)
Marly-le-Roi
2013 - 2016
Coordination & Project Management for the production of phase III & first commercial batches of new vaccines (Malaria, Dengue, Rotavirus).
Management of technical transfer activities.
Management of new product change control.
Support for file submission, Q&A, audits.
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GlaxoSmithKline
- Process Validation Project Manager
Marly-le-Roi
2013 - 2013
Process risk analysis.
Evaluation and Categorization of Process Parameters.
PPQ batches.
Changes impact assessment.
New products & Lifecycle.
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GlaxoSmithKline Biologicals
- Process Validation Engineer
Marly-le-Roi
2007 - 2013
Responsible for global validation strategies regarding Process Validation related expertises (chromatography and TFF lifetimes, product homogeneity, storage, inactivation):
- Guidances update
- Support to manufacturing sites for strategy definition and presentation during external audits (FDA, WHO,...)
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Akka Technologie
- Consultant industrie pharmaceutique (Sanofi Pasteur)
Paris
2006 - 2007
Technical project management regarding Formaldehyde replacement by H2O2 for production area decontamination:
- efficiency technical studies,
- suppliers selection
- Implementation strategy
- IQ/OQ/PQ
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Merial
- Ingénieur Pilot Plant
Lyon
2005 - 2005
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Biocentrum - Denmark Technical University
- Stage laboratoire
2004 - 2004
