Annabelle da Fonseca
Head of Quality Assurance Gestion De Projets Europe @Takeda
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WORK HISTORY
Head of Quality Assurance Gestion De Projets Europe @Takeda
Ville de Paris, FR
Animation JQP 24 - IA appliquée aux activités pharmaceutiques exploitantpréparation audit compliance (anticorruption, liens avec les HCPs/HCOs, gestion des vendors, procedure alerte.)participation conformité organisation qualité EUCANConformité du SMQ (deviation, CAPA, politique qualité, KPIs.) Leadership et gestion d\'équipeGestion des inspections / auditscoordinateur local gestion de criseAuditeur industries pharma certifié GMP/GDP/GCP
EDUCATION
ENSAIA
DESS
Université Paris Cité
DU auditeur industries pharmaceutiques
ESSEC Executive Education
Executive MBA
IAE Paris - Sorbonne Business School
DU management des risques
Pierre and Marie Curie University
Biochemistry master
ABOUT ANNABELLE DA FONSECA
More than 20 years of professionnal experience in industry (food company, medical devices and pharma) focusing on quality management, compliance and international models on manufacturing sites and commercial sites. Experienced in leading changes on quality organisations. Active member of LEEM and other industry organisations.Key areas of expertise are - auditing- quality management- compliance - suppliers and distributors management- medical devices vigilance- GCP/GMP/GDP auditor qualified- FDA regulations- management of HA inspections- transport logistic- GXPs tools qualification/validation- risk mangement- crisis communication- deviation- process optimization - KPIs- Blood and plasma product - Vaccine - Oncololy - Gastro enterologie- recall and defect management
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