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Marion ALIAS

En résumé

With 4 years of professional experience in the QA field of the pharmaceutical industry, I want to fully develop myself in a challenging operational QA position. Back from a rich experience traveling, I am available immediately and flexible regarding relocation. My discipline and my interpersonal skills will enable us to develop new projects together.

Mes compétences :
Gestion de projet
Assurance qualité
Lean management
CAPA
GMP
ICH
Management
Problem solving
Déviations
Biologie

Entreprises

  • Laboratoires macors - Project Manager

    2014 - 2014 Drive CAPA implementation following clients and health authorities audits
    Implementation of a risk management approach according to ICH Q9 for the manufacturing of solid pharmaceuticals products (risk analysis & procedure)
  • Traveler - Traveling Australia, New-Zealand & South East Asia

    2014 - 2015 Personal project: improving my oral English skills
    Developing myself in an independent trip full of challenges
  • Novartis - Process & product expert

    RUEIL MALMAISON 2012 - 2013 * Manage risk analysis (FMEA) relative to mix-up on 15 packaging lines
    * Drive action plan implementation following FMEA (116 actions, 25 owners)
    * Manage line clearance process improvement project
    * Technical review and approbation of master batch records
    * Product & process deviations & complaints investigation
  • Novartis - GMP compliance Laboratories & Bulk officer

    RUEIL MALMAISON 2012 - 2012 * Identify deviations towards GMP and quality requirements
    * Investigation of QC laboratories, stabilities & bulk manufacturing deviations
    * Drive CAPA remediation plan and measure CAPA effectiveness
    * Provide the management of the technical Change Control
    * Provide GMP training to production and laboratories associates
    * Collect all the Quality information and monitore KPI
    * Participate to health authorities audit (Swiss Medic, ANVISA)
  • Famar - Validation Responsible

    Paris 2011 - 2011 Equipment qualification & cleaning validation (autoclave, labeller)
    o Elaborate risk analysis and determine the tests
    o Write validation protocols
    o Coordinate and realize tests
    o Analyse results and write validation reports
    o Give starting authorization
  • Sanofi Pasteur - OUTSOURCING ASSISTANT (Internship)

    Lyon 2011 - 2011 Successfully deployed continuous improvement project according to Lean Six Sigma methodology (Five why, fishbone, voice of customer, …)
  • Laboratoires Macors - QUALITY ASSURANCE ASSISTANT (Internship)

    2010 - 2010 - Document management system improvement
    - Cleaning validation of tanks after a “dirty” long term storage
    - Analytical validation optimization
    - Equipment qualification
    - Project ISO13485 certification: update of SOPs

Formations

  • Faculté De Pharmacie QMPS (Dijon)

    Dijon 2010 - 2011
  • Université De Bourgogne

    Dijon 2006 - 2010 Master 1 Biologie - Santé Option Biochimie

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