Vincent LESAFFRE

En résumé

Entreprises

• Lilly France - Technical Packaging Expert

  neuilly sur seine 2011 - maintenant Mission:
  In charge to ensure qualified state of production equipment
  Approve all documents related to production equipment
  Approve deviations from production and maintenance
  Approve changes of equipment
  Approve all project documents
  Develop and maintain in-process control strategies
  Define strategies for qualification and maintenance
  Develop and maintain the skills of support services
  Participate in internal audits and regulatory inspections
  Develop partnerships with suppliers and providers
  Share and strengthen the link with the corporation

• Lilly France - Qualification Engineer

  neuilly sur seine 2006 - 2011 Mission:
  In charge to manage the qualification activities.
  Project Qualification Coordinator (design, commissioning, Optimization):
  Pen Assembly line – Apollo 3 line
  Blister packaging line - IBCI line
  Vial packaging line – LPF line
  Automatic cartridge inspection line – CAS 3
  Production line with supervisor (SCADA) and interfaced with MES system
  Defining strategies for qualification,
  Definition of impacts on production equipment during transversal project
  Coordination of the qualification activities, resources, schedule, follow-up,
  Main contact about qualification activities with the Corporation,
  Writer of production and qualification procedures
  Approval of qualification documents, production and maintenance,
  Participation in audits and regulatory inspections,

• Lilly France - Production support Experiences

  neuilly sur seine 1999 - 2006 Mission:
  In charge to ensure compliance with regulatory requirements (FDA, AFSSAPS).
  Qualification Packaging lines, assembly lines of pens,
  In charge of Qualification for new systems: Checkweigher, Labeler, Assembly machines RECON, Recycling cartridge system,
  Qualification Vision System (SEIDENADER, Cognex, VISIOTEC, LEATUS)
  Qualification automated systems with design 21 CFR Part 11,
  Qualification of production rooms,
  Writer of qualification documents (IQOQ, DQR, CLA, DSP, CQVP, …)
  Writing of technical studies,
  Optimization of production equipment,
  Animation and people training meetings,

• Lilly France - Formulator of insulin

  neuilly sur seine 1996 - 1999 Mission:
  To start the new insulin building.
  Formulator of insulin, qualified to work in sterile area
  Participation in the development of electronic ticket production (Flowstream)
  Preparer in production equipment and primary component
  Writing operating procedures of equipment

Formations

• Lycée Baudimont Saint Charles

  Arras 1992 - 1994 BTS Biochimie

Réseau

• 'bruno 'VENDRIN

• Christophe GONTIER

• Damien PELTIER

• Laurence PELTIER

• Marie DE BONNEVAL

• Olivier CHRISTOPHE

• Pascal FERNANDES

• Sébastien VIOT

• Stéphane BOURGEAY

• Stéphane BURCKEL