Decleves Dimitri

QA Operations Bulk & System Manager chez Takeda

Charleroi Metropolitan Area

About

Experience

  • QA Operations Bulk & System Manager at Takeda
    Jan 2019 - Present · 7 yrs 6 mos

  • QA Ops Bulk and System Sr Supervisor at Shire
    Mar 2015 - Present · 11 yrs 4 mos

    QA operations bulk and critical system team management. • Batch record review and release following planning by QO bulk team. • Impact evaluation and approval of exception report. • Participation to CAPA and problem solving. • Review and evaluation of critical changes. • Quality on the floor deployment.

  • Baxter International Inc. (Lessines)
    • Quality in Operation Bulk and Critical System Supervisor
      Dec 2007 - Present · 18 yrs 7 mos

      • Deployment and management of QO bulk and critical system team. • Development of batch record review and release following planning by QO bulk team. • Impact evaluation and approval of exception report. • Participation to CAPA and problem solving • Review and evaluation of critical changes (CR, NI, DCR).

    • Cleaning Validation Engineer
      Apr 2001 - Nov 2007 · 6 yrs 8 mos

      • Validation of new equipment for news production lines. • Process Revalidation of current equipment. • Problem solvingrelated to cleaning issue. • CIP cycle development.