Experience

ABL Europe

• France
• Research Services

• Quality Manager

  • Jun 2021 - Dec 2022

  Lyon, Auvergne-Rhône-Alpes, France - Define Site Quality Organization to ensure resources and systems are in place - Support preparation / execution to health authorities inspections and audits - Promote Quality Culture - Oversight of Quality Strategy and budget



FAMAR

• Greece
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality System Manager

  • Jan 2017 - Jan 2021

  Région de Lyon, France - Quality System: Documentation, CAPA, PQR, Customer audits & inspections, Internal audit, Change Control, GMP training - Supplier Evaluation : Complaints, Evaluation & qualification, Quality contracts (QTA), External audits - Qualification / Validation: Process, cleaning, equipment - Quality Control: Environmental monitoring, retain library management

• Quality Operation Manager

  • Jan 2013 - Jan 2017

  Région de Lyon, France - Deviations & Complaints: Root cause analysis, CAPA plan, Customer communication - Batch Release / Certification - Internal audits in Manufacturing Areas - Customer audits / inspections



Mylan

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA Third Party Pharmacist, injectable products

  • Nov 2007 - Jan 2013

  Saint Priest, France QA Products : Batch release, complaints, process deviations, change control, stability studies, PQR, MAD compliance Third Parties Management: Audit, approval of validation protocol/report, master batch record, certificate of analysis and technical agreement QA System: CAPA, documentation, internal audit, indicators, training, regulatory inspections. • Project management: Support for products launch, Trackwise® implementation for complaint and change control



Laboratoire Aguettant

• France
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• QA Production Pharmacist, injectable products

  • May 2006 - Nov 2007

  Lyon, France Process and analytical deviations CAPA Master batch records : implementation, maintenance and review for batch release Process validation, cleaning validation, equipment validation, Media Fill Test Change control Audits and regulatory inspections Training : GMP, visual inspection, hygiene and microbiology



Genzyme

• 1 - 100 Employee

• Quality Control Training

  • May 2005 - Sep 2005

  Marcy l'Etoile, France Internal audit of Immunology, Microbiology and Physico-chimistry Laboratories Process optimization: Analysis flow - Equipments management - Reagents and references management Follow-up : productivity, costs and quality improvement



Groupe d'Intérêt Public ESTHER

• Clinical training

  • Mar 2004 - Sep 2004

  Siem Reap, Cambodge Internal audit, implementation of care protocol (HIV) and trainings for medical staff