Menu

Nicolas BRUNET

Lingolsheim

En résumé

Responsible for providing leadership and oversight in Corporate Project Management (Corporate Quality Control) and laboratory testing processes - ECA Certified QC Manager.

Mes compétences :
GAMP
manager
conseil
ingénierie
instrumentation
marketing
vente
santé
business
chimie

Entreprises

  • Octapharma - Corporate Project Manager

    Lingolsheim 2015 - maintenant Lead corporate projects in corporate Quality Control.
    Monitor and report project progresses, identify issues and suggest corrective actions with robust argumentation.
    Develop and maintain synergies and harmonization across sites.
    Build corporate SOPs and guidelines, review and approve corporate documents.
    Promote Best Practices and implement Risk Management tools.
    Act as a Quality Control expert providing support to local Quality Control departments.
    Represent Octapharma in front of external organizations.
    Lead auditor: incoming goods manufacturers & service providers.

  • Octapharma - Head of QC Raw Materials

    Lingolsheim 2012 - 2015 Responsible for providing leadership, management and oversight of raw materials inspection and laboratory testing processes.
    Lead the development, revision, application, maintenance, qualification, validation and review of quality standards, documents, equipment and methods for processing and ensuring quality in raw materials.
    Provide effective leadership including: individual goal setting/performance reviews, provide coaching and managing the development of employees (7 people), planning and facilitating team activities.

  • ThermoFisher Scientific - Market Segment Manager

    VILLEBON SUR YVETTE 2008 - 2012 Drive marketing development plans by market segments (Pharma/ Biotech Industries), by application and in the Key-accounts, to achieve revenue and margin goals.
    Key responsabilities:
    Set up the Strategic Plan for the pharma/biotech segment
    Own the product roadmap and work together with Product Management to ensure successful execution on the roadmap development
    Drive the sales pipeline growth for the segment and establish tracking metrics
    Develop Market Analysis, Customer trends and SWOT analysis
    Set up and coordinate strategic collaborations and joint development partnerships (with manufacturers/suppliers) in the pharmaceutical segment
    Travel with sales to customers and conferences to promote Thermo Fisher Scientific and to give both technical and corporate presentations
    Set pricing to meet revenue and profitability goals
    Develop dedicated marketing programs (i.e. start-up customers)

  • GSK Biologicals - Lab equipment Validation Supervisor

    Marly-le-Roi 2006 - 2008 Set up the QC equipment qualification master templates (such as URS, IQ, OQ, PQ) applicable on all GSK biological sites
    Generic protocols approval (HPLC, COT, spectrophotometer, ...)
    Qualification tests execution (HPLC, Atomic absorption spectrophotomer, ICP-OES...)
    Perform 21CFR Part 11 compliance assessment of computerized laboratory systems
    Writting of a Global SOP covering each steps of the V-model from URS to PQ, and including supplier/manufacturer selection

    Contractant (CVO Cyberconseil) from 2006 October to 2007 December and GSK Internal from 2008 January to 2008 March.

  • Octapharma - Trainee - QC Validation

    Lingolsheim 2006 - 2006 Set up QC equipment qualification strategy:
    Validation Master Plan update
    Writting of a local SOP for the QC equipment qualification
    Preparation of qualification documents such as IQ, OQ, PQ
    Execution of IQ, OQ, and some PQ studies. Compilation of data and summary reports

Formations

Réseau

Annuaire des membres :