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Xavier VAN ROY

Paris

En résumé

PERSONNAL OBJETIVE:

Take full benefit of my >20 years of experience in bio-pharma and my strong Laboratories Information Management System (LIMS) & e-analytics expertise to contribute to companies ‘s organization and process efficiency through optimal system integration, while focusing on quality assurance and compliance.

EXPERTISE:

- LABWARE LIMS Administration certification
- Project Management (Use of PMI Methodology)
- Computerize System Qualification (GAMP)
- Data & Knowledge management
- Process Thermal Hazard Evaluation (Stoessel’s Methodology)
- Process Analytical Technologies
- Scaling-up from laboratory to industrial scale, according to cGMP rules

STRENGTHS:

- Customer and Result oriented, trough strong involvement into the business
- Strategic Thinking (Analytical mindset – Creativity/Innovation)
- Listening
- Quick learner
- Interpersonal Skills
- Team Work Skills

I believe in the power of networking, that's why I am a LinkedIn Open Networker [LION]. Please feel free to connect with me

Mes compétences :
GxP
Quality Control
Computer System Validation
Project Management
Team Spirit
LIMS

Entreprises

  • Sanofi - BioLIMS - LabWare 7 - Phase II Validation

    Paris 2020 - maintenant
  • Sanofi - BioLIMS - LabWare 7 - Phase I Deployment

    Paris 2019 - maintenant
  • Canon - LabWare ELN Project

    Courbevoie 2019 - 2019
  • Apb - LabWare LIMS Implentation

    Bruxelles 2019 - 2019
  • Glaxosmithkline - LIMS Business Analyst - Clinical LIMS

    Marly-le-Roi 2016 - 2019
  • Projexia SPRL - Managing Director & Owner

    2015 - maintenant Projexia, the link between Business and IT for your Biopharma Company

    With 20 years of experience in bio-pharma and a strong Laboratories Information Management System (LIMS) & e-analytics expertise Projexia will contribute to your companies ‘s organization and process efficiency through optimal system integration, while focusing on quality assurance and compliance.

    Spécialisations :
    LIMS & ELN, Process Analytical Technonoly, Scale-up, Computerize System Validation
  • GlaxoSmithKline - LIMS Business Analysis - ROXIS

    Marly-le-Roi 2014 - 2015
  • Senior Consultant - Freelance - Business Analyst with 19 years experience in BioPharma

    2014 - 2015
  • UCB - LIMS System Associate

    COLOMBES 2013 - 2014 As Subject Matter Expert :

    - Be the key contact between Business and IT Support Team :
    - Drive implementation & improvements of LIMS Process (Project Mgmt, Planing, quality & feasibility, cost...).
    - Support Global Process Owner until solution implementation and maintain technically the system after Go Live.
    - Support Global & Local Key Users during Users Requirement Specification (URS) definition, validation phase (Operational Qualification (OQ)/ Performance Qualification (PQ) ) and business implementation.
    - Permanent Member of the LIMS Change Advisor Board.

    As Global Process Owner (LIMS Administration and LIMS-SAP interface) :

    - Be a Global Business Representative :
    - Collect and challenge requirement with a global approach.
    - Review and approbation URS and ensure adhesion of local business.
    - Participate to validation phase (OQ/PQ), and guarantee adequacy with URS.
    - Challenge, after go live, new business requests and ensure the consistency of these.
  • UCB - G-LIMS Team Manager

    COLOMBES 2012 - 2013 - Manage the global LIMS Team (6 direct reports + 4 dotted reports )
    - Ensure successful administration of the Team through staff performance management and financial objectives.
    - Drive implementation & improvements of e-Analytical tools (Project Mgmt, Planing, quality & feasibility, cost...)
    - Provide robust and seamless system around e-Analytical tools (global SOP, Change Control, Development & Validation of interfaces with others systems)
    - Work with QA to ensure compliance, RA to ensure high quality and timely submission documentation.
  • UCB - Local G-LIMS Administrator

    COLOMBES 2010 - 2012 Ensure the local development & implementation of any electronic Analytical tool and provide local support to the network as needed. (QC's and Analytical Development lab's for Braine (Belgium) and Slough (UK))
  • UCB - Associate Scientist

    COLOMBES 2002 - 2010 Act as specialist in high technology tools for chemical process understanding and optimization by the use of automated equipment and statistical tools
  • UCB - Development Technician

    COLOMBES 1995 - 2001 Development and industrialization of chemical process from lab scale to full scale validation.

Formations

Pas de formation renseignée

Réseau

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