Menu

Mathieu MARROT

huningue

En résumé

Since 2007, I had the opportunities to work for different companies and to be in contact with different people with different point of views.
Thanks to these experiences I have learned a lot in different fields such as Utilities, Qualification, Aseptic area & Filling. I am currently using this knowledge to handle small scale modifications on filling lines with a team of competent people.

Always eager to learn and motivated by challenges do not hesitate to contact me if you wish to discuss further.

Mes compétences :
Biotechnologie
Industrie pharmaceutique

Entreprises

  • DELPHARM - Qualification, Validation & Metrology Manager

    huningue 2012 - maintenant Hormonal Gel
    Manufacturing & Packaging Operations
    EMEA & Brazil Regulations


    Define and ensure Validation strategy (VMP) including
    - Equipment/Utilities Qualification
    - Process Validation
    - Cleaning Validation

    Project Management (New Product/New Equipment)
    - Involved in URS
    - Risk Analysis
    - FAT/SAT in collaboration with suppliers
    - Supervise Qualification/Validation activities

    Audit
    - Person of Contact for Qualification, Validation & Metrology activities (Brazil & EMEA Authorities & Clients auditors)

    People & Budget Management
    - Supervise 1 officer & consultants
    - OPEX management

  • GlaxoSmithKline - Packaging Engineer

    Marly-le-Roi 2012 - 2012 [De Valck Consultants by Altran]

    GTS - Global Technical Services
    Project management

    Tasks :
    - Point of contact with suppliers and production
    - Qualification of cartoning machine

  • Next Pharma - Project Manager CMS

    2011 - 2011 (De Valck Consultants - Altran Lifesciences)

    CMS (Contract Manufacturing Services) - Project Manager

    Tasks :
    - Point of contact with customer
    - Follow up of different products
    - Coordination with all intern Departments (QA, QC, Production, Engineering, etc.)
    - Follow up of Change Control, Process Validation, etc.

  • IBA - Validation and Verification Manager

    2011 - 2011 (De Valck Consultants - Altran Lifesciences)

    QUALIRY ASSURANCE - Validation and Verification Manager

    Tasks :
    - Ensure that procedures are applied
    - Follow-up projects
    - Improve quality within the company

    Environment :
    - ISO 9001
    - Cyclotrons

  • GlaxoSmithKline - Project coordinator

    Marly-le-Roi 2009 - 2011 (De Valck Consultants - Altran Lifesciences)

    FILLING - Support Maintenance for both Wavre and Rixensart sites
    Project coordination of production lines improvement.

    Tasks :
    - Point of contact with provider
    - Point of contact with all departements involved in the project (Validation, QA, Process Control, Production, Maintenance, QC, Engineering, etc.)
    - Reviewer of commissioning documentation
    - Reviewer/Author of validation documentation
    - Troubleshooting
    - Cost management
    - Time management

    Environment :
    - Isolators
    - Vials filling system (TPF)
    - Vials washing installation
    - Stopper washing installation
    - Anti-mix-up system

  • Debiopharm - Compliance engineer

    Lausanne 2009 - 2009 (De Valck Consultants)

    ----- PREPARATION AUDIT FDA -----

    *** WFI / PW / CS ***
    - technical audit of equipments
    - improvement proposal
    - implementation of new operational and maitenance organisation

    *** HVAC ***
    - technical audit of equipments
    - implementation of new strategy for environmental qualification and monitoring
    - implementation of new operational and maitenance organisation
    - collaboration with QC, production, maintenace departments

  • UCB - Qualification engineer

    COLOMBES 2007 - 2008 (De Valck Consultants)

    *** HVAC ***
    - write company's official paper to define critical parameters for GMP rooms (team task)
    - understand the needs of all Departments (Oral Dosage Forms, Sterile, Development, etc.)
    - choose Qualification's strategy (team task)
    - write Qualification's documents
    - train people

    *** WFI / PW / Packaging line ***
    - resolve deviations observed during previous qualification steps
    - continuously check legislation texts, Guidelines and technical papers to provide solutions in agreement with Pharmacopoeias and international Regulations
    - communicate with people involved in the project and ensure coordination between different services
    - be proactive
    - choose Qualification's strategy
    - write Qualification's documents
    - train people
    - corporate audit

  • CEVA PHYLAXIA - Development engineer

    Madrid 2006 - 2007 CEVA SANTE ANIMALE is a veterinary pharmaceutical laboratory which encompasses all the aspects of the animal health business, from development of the products all the way through to their sale in most countries worldwide.
    -------------------------------------------------------------------

    During my internship, I worked in the ELISA unit and my project was to develop and to validate a test which allowed quantifying K99 adhesins from Escherichia coli. This test was then used in order to optimize the production process of a vaccine.

Formations

Réseau

Annuaire des membres :