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Julien ROCHE

Romainville

En résumé

Looking for job oportunities accros Europe !

Mes compétences :
Change Management
Aseptic processing and management
production support
Team Management
SAP implementation
Project Management
Operationnal Quality management
Internal Audit
External Audit
Qualité

Entreprises

  • FAREVA - Quality Assurance Manager

    Romainville 2013 - maintenant European Pharmaceutical Contract Manufacturer Blow-Fill-Seal / sterile ophtalmic plant.

    In charge of :
    * Customer Quality Relation ;
    * Operationnal Quality management (complaints, deviations, production support)
    Sterility Assurance (PDA member for Aseptic processing and management)
    * Authorities inspections and relations
    * Batch certification and release

    * 15 peoples management ;

  • FAREVA - Quality Compliance Manager

    Romainville 2008 - 2013 European Pharmaceutical Contract Manufacturer Blow-Fill-Seal / sterile ophtalmic plant.

    In charge of :
    * Customer Quality Relation
    * Internal / External audit ;
    * Change control/CAPA/Documentation systems ;
    * Sterility Assurance (PDA member for Aseptic processing and management)
    * Authorities inspections and relations
    * FDA certification ;

  • Haupt pharma - Head of Quality Assurance / QP

    2007 - 2008 European Pharmaceutical Contract Manufacturer injectable production plant.

    In charge of :
    * Customer Complaint
    * Internal audit
    * Validation and change control
    * GMP Trainings
    * Metrology and w.f.i production
    * Internal non-conformity.
    * All pharmaceutical componant's release.

    13 people's team management

  • Haupt Pharma Livron - Head of Quality / Qualified Person

    2007 - maintenant

  • Haupt Pharma Livron SAS - Quality Compliance Manager

    2006 - maintenant In charge of several QA Topics :
    - Validation
    - Change control
    - Metrology
    - Customer Complaints
    - Internal non-conformity
    - Training

  • Haupt pharma - Quality Compliance Manager

    2004 - 2007 European Pharmaceutical Contract Manufacturer injectable production plant.

    In charge of :
    * Customer Complaint
    * Validation and change control
    * GMP Trainings
    * Metrology and w.f.i production
    * Internal non-conformity. ;
    * Packaging, Raw material and Bulk control and release. ;

  • Solvay Pharmaceuticals - Trainee

    2004 - 2004 Trainee within the framework of a project of contruction of a site of excellence of production. In load of the technical follow-up of the installation again equipment, installation of the documentary system accompanying starting by a new site with aiming FDA, actor in the realization of the tests of valiation.

  • Haupt Pharma Livron - Validation and Change Control Manager

    2004 - 2006 In charge of :
    - validation master plan redaction and creation
    - Change control management
    - metrology services

Formations

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