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Emmanuel GRANDVILLAIN

NEUCHÂTEL

En résumé

As a Quality Project Leader / Representative I am passionate about project management, problem identification / solving, Identifie areas of improvements within Quality departement.

I have strong knowledge regarding material management, international regulations and industry related guidances (FDA, EMEA, EU guide vol 4, ICH...)

I have good interpersonal / communication / influencing and negotiation skills and a strong background in Pharmaceuticals and Biotechnology industry.

Good listener and cooperation skills, I work closely with the other departments involved in the change control process.



Mes compétences :
Crystal Report
CAPA
Raw material
Assurance qualité
Material Management
Gestion du changement
Contrôle qualité
ASTM 2500
Reduced testing
Leader coach

Entreprises

  • Baxalta - Quality Project Representative

    2015 - maintenant

  • Baxter International - Quality Project Leader Raw Material

    Maurepas 2013 - maintenant Ensure the implementation of Quality and/or cross-functional projects related to the Neuchâtel facility.
    - Leads and or participates to Quality related project (Quality systems improvement, lean initiatives, CAPA…)
    - Identifies areas of improvements
    - Participates to internal or external assessments, as required. Support process with timely closure of observations/audit items.

    Strong knowlege of Material / Raw material management.

  • Baxter International - IS LIMS Leader

    Maurepas 2012 - 2013 Lead the LIMS (Laboratory Information Management System) team in the definition, implementation and operation of the infrastructure required for efficient internal and external facing operations.
    Provide direct supervision of individuals including mentoring and performance management.
    Work in a direct partnership with QC management and further Quality and Operations functions to ensure adequacy and appropriateness of in-process parameters and product specifications.
    Drive the routine equipment/system, computer system and product validations of my area.
    Ensure that all documents and procedures are properly and in a timely manner completed and documented.

  • Baxter Bioscience - QC Expert - LIMS Coordinator

    2011 - 2012

  • Delpharm - LIMS Coordinator / Administrator

    huningue 2007 - 2011 LIMS Coordinator (4 sites)

    • Management of the whole Starlims System
    • Qualification and validation of protocols changes.
    • Development and validation of new applications. Test scripts validation for system upgrades
    • Identify, analyse, and offer support for all Starlims applications issues.
    • Training of manufacturing site administrators (Use of Starlims, Crystal Report). Provide training and support all Starlims system users
    • Interface realization and validation tests with ERP SAP.
    • Creation of the Crystal Report templates: Working sheet, Certificates of analysis, Certificates of compliance, etc.
    • Creation of the operating modes and procedures group.
    • Direct contact between Starlims France and Delpharm for the correction management and software evolutions.
    • Ensure coordination with IT and QA Validation departments
    • Basic understanding of SQL

    Lims Administrator (Delpharm Chambray-lès-Tours facility)

    • Parameter setting of analyses realized in the laboratory: Raw material, finished product, stability.
    • Develop and maintain Standard Operating Procedures, user guides, test plans and other relevant system documentation and ensure compliance with cGMPs
    • Training of Starlims users

  • Delpharm - Quality Control Analyst

    huningue 1999 - 2007 * Perform semi finished product testing: work closely with production and manufacturing departments
    * Perform raw material, finished product and stability testing
    * Performs routine maintenance of equipment (HPLC, GC, UV, pH-meter…)
    * Use of the Good Manufacturing Practice. Analyses realized according to the European, US and British pharmacopoeias.

Formations

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