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François DUCLOS

Boulogne-Billancourt

En résumé

Graduated with a Master Sc in Biotechnology engineering.
Experienced in process validation (cleaning and sterilization) and process improvement focused.


Specialties:
* Process validation (V-Cycle, ASTM E2500)
* 6 Sigma green belt training (not certified)
* Root cause analysis (5M; 4 why; advanced problem analysis CRT)
* Regulatory knowledge (EMA; FDA; ICH)

Mes compétences :
Analytic
Bioproduction
Communication
Management
Manager
Process
Quality
Quality management
Regulatory Affairs
Results Oriented
Scale up

Entreprises

  • Roche - MSAT Engineer DSP

    Boulogne-Billancourt 2014 - maintenant

  • Baxter International - Validation engineer

    Maurepas 2012 - 2014 Washer and depyrogenation vials tunnel validation
    Stopper processor system validation
    Coordination of three first commercial batches for new filling complex

  • Altran - Life Sciences consultant

    Vélizy-Villacoublay 2011 - 2014 Life Sciences Consultant.

  • GlaxoSmithKline - Validation engineer

    Marly-le-Roi 2011 - 2012 Cleaning validation (CIP, manual cleaning, washing machine).
    Moist Heat Sterilisation validation (autoclave)

  • European Medicines Agency - London - Scientific Administrator - Quality of Medicines - trainee

    2009 - 2010 Scientific evaluation of quality variations (IA, IB, II) for centrally authorised products (Module 3).

    Coordination of scientific advice at the Biological Working parties and CHMP regarding quality issues for medicinal products in development (reports, meetings, updates).

  • Sanofi - Quality assurance - trainee

    Paris 2008 - 2009 Set up of GMP documentation (SOP's) for antibodies manufacturing pilot.

  • Sanofi - Materials Quality engineer - trainee

    Paris 2008 - 2008 Quality and safety for materials of animal origing monitoring.
    KPI's for safety coverage regarding TSE exposure.

Formations

Réseau

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