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Operations Support Lead

SCIENCE TALENTS in BRUSSEL
time Online sinds 30 oktober 2024 - Vaste jobs

  • Coordinate, manage and control all quality aspects related to support production activities:
    • Documentation (incl.Procedures, logbooks, enz.)
    • Back-up for the Operations supervisor
    • Inspection on documentation and GMP housekeeping in the support production zones
  • Control QMS documentation (in line with c.GMP) in collaboration with MS&T and Quality:
    • Deviations/events, and CAPA
    • Support communication concerning KPI’s related to quality aspects in Production
  • 2nd point of contact representing Supporting Production quality matters in internal & external audits
  • Support optimisations of current processes within the support production areas
  • Provides support to writing and revising SOPs and associated documents
  • Works daily in a cleanroom manufacturing environment.
  • Controls and maintains the environment (equipment & facility cleaning and environmental monitoring) of the GMP production areas
  • Manage packing, sealing and sterilisation of materials and documents
  • Manage timely transfer of apheresis material, raw materials, consumables to the applicable clean room and manage timely final product transfer
  • Manage inventory counts, preparation of internal order
  • Be present at the daily start of shift operations meetings and the daily wrap up production meetings
  • Act as a SPOC to the logistics warehouse for the material availability in the supporting production areas.
  • Manage inventory in the WIP and storage of cleaning agents.
  • Communicates clearly with the Supervisor and Operations Technical Clean Room Lead to highlight on clean room status/material transfer status or any items related to safety, quality and efficiency