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Dorle LESCOT SANCHEZ

MEUDON

En résumé

Mes compétences :
Quality management
Qualité
Assurance
Agroalimentaire
Biotechnologies
Pharmacie
Business
Gestion administrative
Quality Control
Quality Assurance
Staff Development and Training
Biotechnology
Audit
technical support
stability analysis
analysis of process validation and Stability studi
Risk Analysis
Responsible for the documentation system
Minitab
Microsoft Visio
Microsoft Project
Microsoft Office
Lean Manufacturing
LIMS
Immunization
ISO 900X Standard
ISO 14001 Standard
Design of the Quality systems and policies
Analytical testing

Entreprises

  • Neovacs - CMC Study Coordinator

    2017 - maintenant
  • ABMI - Project Manager

    Saint Priest 2013 - 2016 Biotechnology (Insuline)
    Missions:

    * Project Manager for Utilities department.(Clean Steam, Compressed Air and Water for Injection systems)
    * Validation Engineer in Quality Control department (Air test, Particle counters validation and several
    projects)
    * Validation Engineer and Coordinator in documentation for Wash and Sterilization department in a
    Compliance Projet (CPE, Utensil Washers)
  • Bioorganic Research and Services - Quality Assurance Manager

    2009 - 2011 Management of the Quality Assurance Department for the Biotechnology Manufacturing Site in Jerez de la Frontera and the Development and Research Laboratory in Seville.
    Knowledges of the Protein recombination process.
    Design of the Quality Control and Quality Assurance systems, Audit process compliance (ISO 9001, UNE 166002, Regulatory Authorities of Spain and Chile), Critical Control Points in Process, Deviation System, Technical Assistance with laboratory tests, DMAIC methods to find solutions to issues and technical problems.
    Involved in the Regulatory Affairs, principal contact with the Regulatory Agency of drug products in Spain.
    Responsible for the documentation system (SOPs, Registration Formats, Reports)
  • Pfizer - Tech Transfer Technology

    Paris 2006 - 2008 New product launches “Factive 5 tablets 320 mg: “Americas Award” for the in a record time.

    Abilities developed in Project Management
    Budget Forecast, Budget administration, budget reports,
    Deadline schedule monitoring.
    Process Review in coordination with other departments (manufacturing, supply chain, technical services)
    Management of 16 chemists in the laboratory activities, non direct management, two engineers in the quality assurance department and two documentation specialists at the regulatory affairs area.
  • Pfizer - Team Leader Validation

    Paris 2003 - 2006 Missions:

    * Team leader for Analytical Method Validations, analysis of process validation and Stability studies.
    * Writing protocols, and review of Validation and Stability reports
    * Review of master files for the feasibility of the implementation in laboratory. ;
    * Team leader for the New Product Launch Committee. ;
    * Involved in the decision making.
    Award:

    * New product launches in record time ``Factive 5 tablets 320 mg: ``Americas Award.
  • Grupo Alimenta - Sales Executive

    2003 - 2003
  • Schering Plough - Analytical QC

    Hérouville-Saint-Clair 2001 - 2003 Pharmaceutical company
    Missions:

    * Perform of the analytical tests of Cleaning process from a protocols, stability analysis, raw material and
    finished product analytical test for release.
    * Proficiency in HPLC (Waters, Agilent) Gas Chromatography (Agilent), Atomic Absorption, dissolution, ie.
    * Review of Master files for key OOS and OOT investigations.



    * Page 2 Ph. +33 641 320 699

    Internships in Food Companies
  • AMCO International - Stage-Chemist, Quality Control

    2000 - 2001
  • Cadbury - Analytical QC

    Paris Cedex 1997 - 1997 beverages, Analytical testing, sampling activities and sensory evaluation.

Formations

  • Alliance Française (Paris, Ile De France)

    Ile De France Paris 2011 - 2013 B2

    langue Français
  • ESERP BUSINESS SCHOOL (Madrid)

    Madrid 2008 - 2009 Master of Business Administration

    (Master in Business Administration) ESERP Business School, Madrid Spain.
  • ITESM (Tec De Monterrey) (Mexico City)

    Mexico City 2006 - 2007 Administration of pharmaceutical companies

    (Diplome) ITESM (Instituto Tecnológico de Estudios Superiores de Monterrey), México City.
  • UNAM (Mexico)

    Mexico 1994 - 1999 Bachelor of Science

    UNAM (Universidad Nacional Autónoma de México), México City

Réseau

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