QA System Expert
Pharmadiem
Lille, FR
il y a 1 mois

La société Pharmadiem, spécialisée en management et ingénierie des grands projets recrute un Expert Spécialiste QA System confirmé pour le compte d’un de ses clients en Belgique.

Vos missions :

  • Ensures Efficient Management and Execution of the Event & CAPA Process (GEMS). Ensures that events / CAPAs and associated investigations are appropriately and timely performed and documented.
  • Ensure that reports are available. Supervise and support the activities related to Event & CAPA Process (GEMS Trackwise 8) for the Site;
  • Effectiveness of Quality Systems deployment and execution is demonstrated through KPIs and management reviews are being conducted in line with Client Guidance.
  • Define and manage the action plans to ensure KPI are satisfactory.

  • Participate to the Global Event Review Board.
  • Manage the MR of Quality Systems.
  • Manages the Quality Risk Management System.
  • Train employees on EVENT / CAPA system. Monitor the EVENT / CAPA system to ensure compliance to the Global procedures and Regulations and evaluate additional need for training / coaching of the users
  • Profil recherché :

  • Master degree in Chemistry / Biology / Quality / Agronomy / pharmaceutical sciences
  • Qualités requises :
  • Min 5 years’ experience in Quality or Manufacturing of biotech or pharmaceutical products.
  • Min 5 years’ experience in leading teams
  • Management and leadership skills
  • Sets clear Priorities, manages through KPIs
  • Excellent communication Skills with teams, peers, global partners
  • Good Organizational skills
  • Autonomous
  • Good English knowledge
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