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Kady ZONGO

TOULOUSE

En résumé

Mes compétences :
Geode+
AMDEC
Microsoft Office
Norme ISO 14001
CAPA
Quality by Design
Norme ISO 9001
TPM
VSM
Lean Six Sigma
5S
QI, QO, QP
Amélioration continue
Lean
Validation des Procédés
Biotechnologies
Dispositifs médicaux
Production Biologie
Gestion de la chaine logistique
Gestion de la production
Essais cliniques
Audit externe
Gestion de projet
Audit qualité
Assurance qualité
GMP
Industrie pharmaceutique
Bonnes Pratiques de Fabrication

Entreprises

  • MERIAL SAS - Quality Assurance Specialist and Engineer (2 Years), in Biotechnologies department

    TOULOUSE 2014 - 2016 - Verifying and reviewing Quality documentation according to the biology production department’s Quality Assurance Plan, according to ISO 9001:2008, and Merial requirements.
    - Optimization and review Master Batch Record appendices, translate the critical process parameters and the strategy of maintaining the appendices in line with the current Merial requirements and cGMP.
    - Implementation of documentary compliance for the Cleaning Validation (Protocol and Report Validation) and creating of a process handbook for the cleaning process in the department according to ISO 9001:2008.
    - Conducting cleaning validation project, writing Protocol and Report Validation.
    - Conducting Continuous Improvement Process (CIP), Value Stream Mapping Project Manager for the equipment headquarters for biology production. Workshop (analyzing and optimizing of processes, implementation of the results, evaluation of the implementations).
    - Project Manager, I participate in improvement and remediation of of the equipment necessary for production of a new active ingredient : provides technical expertise to define and execute product optimization projects and to support manufacturing issues.
  • Sanofi - Intership Quality Assurance Suppliers and Quality Control specialist in Quality Control department

    Paris 2014 - 2014 - Creation terms of service setting up the sampling plan and the most appropriate acceptable level of quality, in accordance with the ISO 2859.
    - Management of supplier claims when levels are not respected.
    - Work closely with Suppliers, QC, Production, and graphics department
    - Participation for Preparation, execution and writing audit reports.
  • Hôpital Européen Georges Pompidou Paris - Internship Quality Assurance in Medical Devices, in sterilization department

    2013 - 2014 - Evaluation of quality of Medical devises sterilization with quality indicators which were already in place.
    - Presentation of new process quality indicators to the executive committee of the hospital’s sterilization department.
    - Monitoring of files and sterilization cycles according to the ISO 11138.

Formations

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