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Virginie CHARLOT

Nanterre Cedex

En résumé

Mes compétences :
Gestion de projet
Quality Control
GMP
Cell Culture
audit preparation
Six Sigma
Relationship management
DMAIC
Change Management
CAPA
Biopharmaceuticals

Entreprises

  • Biogen Idec - Associate Director Supply Chain Quality

    Nanterre Cedex 2014 - maintenant
  • Baxter International - Quality In Operations Senior Manager & Qualified Person

    Maurepas 2013 - 2014 * Direct Management of 3 Supervisors (Bulk Drug Substance, Final Container, Utilities, Facilities, Quality Control) to develop a 45 people team and ensure release, successful facility project completion as well as audit preparation & realisation, ;
    * Build-up of a powerful team to close deviations in alignment with the quality & business need, ;
    * Creation and deployment of a Qualified Person (QP) delegate team to achieve culture of high performance and reliability to reach customer need thanks to constant product availability, ;
    * Ensure QP duties as per Annex 13 and 16 of the EU GMP as well as the Swiss Ordinance, ;
    * Support sister site, leading to EMA approval followed per successful GMP inspection thanks to my coaching & critical thinking ability, ;
    * Relationship management with Swissmedic Inspectorate to ensure appropriate evaluation & communication of license variation, ;
    * Act as an efficient Escort during regulatory inspection (F.D.A., Swissmedic, TEVA ...) allowing GMP certificate renewal as well as approval per required authorities of commercial and clinical product. ;
  • BAXTER BIOSCIENCES - Quality In Operations Manager & QP delegate

    2011 - 2013 * Direct Management of 3 Supervisors (area covered : Bulk Drug Substance, Final Container, Utilities, Facilities, Maintenance, Quality Control) and 3 Project leaders leading to the fulfillment of facility goals in terms of compliance and release, ;
    * Created shared value and behaviors to support the alignment of the QO team members(~40) ;
    * Manage and build the organization to become a recognized Quality partner to deal with in case of event in operational area, ;
    * Excellent review of process validation as well as submission document to reach continuously the facility milestones ;
    * Responsible Technique/Qualified Person Deputy ensuring release of BDS and FC as per GMP requirements. ;
  • BAXTER BIOSCIENCES - Quality In Operation Supervisor

    2007 - 2011 * Direct Management of a 15 people team integrating goals definition and development plan, ;
    * Improvement of partnership between Bulk Drug Substance Production (Cell Culture and Purification) and Quality increasing the efficiency of the shared activities (Change control, deviation, GMP tour...), ;
    * Exception leading to support closure as per GMP requirement as well as release schedule, ;
    * Project leader (Black Belt) to simplify the final container release flow (NVA reduction, accountability increase, workload reduction) as well as reduce per 20% the Human behavior related exceptions, ;
    * Involvement in several inspections as Quality Expert (F.D.A., Canada, Swissmedic). ;
  • BAXTER BIOSCIENCES - Cell Culture Senior Process Engineer

    2001 - 2007 * Startup of a manufacturing line from development/validation protocol execution to approval from regulatory authorities (including support to pre-approval inspection) ;
    * Successful Technology transfer of Bulk Drug Substance Manufacturing to the United-States by building strong relationship with my counterpart, ;
    * CAPA leader allowing manufacturing critical deviation to be solved in a timely manner (DMAIC, 5M, ...), ;
    * Process optimization gaining 2 batches per campaign, ;
    * Smooth Set up of a laboratory needed to support critical raw material release, ;
    * Training of the new cell culture operators to ensure robust and repeatable activities, ;
    * Involvement as technical expert in several successful pre-inspection (F.D.A., Canada). ;

Formations

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