Hybrid Digital Quality Lead — CSV

Il y a 4 jours
Belgique MSI Pharma Temps plein 80 000 € - 100 000 € Contrat
Location:WalloonRegion(hybridworkingmodel)Engagement:12-monthfreelanceengagement(ASAPstart)OverviewWearepartneredwithaglobalpharmaceuticalorganisationtosupportthebuild-outoftheirQualityR&D&Pharmacovigilancefunction.ThisisanewlycreatedBusinessQArolefocusedonoversightofGxPcomputerizedsystems,withaparticularemphasisonComputerizedSystemValidation(CSV)andDataIntegrity.ThepositionsitsattheintersectionofQuality,IT,andbusinessteams,ensuringsystemsarecompliant,fitforpurpose,andalignedwithregulatoryexpectations.Responsibilities
  • ProvideQAoversightofGxPsystemsacrossGCP,GLP,andPVenvironments
  • ReviewandcontributetoCSVdeliverables(riskassessments,validationdocumentation,DIassessments)
  • Supportthefullsystemlifecycle,fromselectionandonboardingthroughtovalidationandongoingcompliance
  • PartnerwithIT,QA,andbusinessstakeholderstoalignsystemusagewithregulatoryrequirements
  • Assessandmitigatedataintegrityrisks,ensuringappropriatecontrolsareimplemented
  • Contributetoinvestigations,deviations,CAPAs,andinspection-readinessactivities
HardSkills
  • ProvenexperienceinComputerizedSystemValidation(CSV)
  • BackgroundinGCPand/orPharmacovigilanceenvironments
  • PriorexperiencewithinpharmaceuticalR&D
  • StrongknowledgeofGxPframeworks(GLP,GCP,GVP)
  • SolidunderstandingofDataIntegrityprinciples(ALCOA+,datalifecycle,audittrails)
  • FluentinEnglish
SoftSkills
  • Abilitytoworkautonomouslyandmanagemultiplestakeholders
  • Strongcriticalthinkingandproblem-solvingcapability
  • Confidentcommunicator,abletobridgetechnicalandbusinessteams
  • Detail-orientedwithacompliance-firstmindset
Qualifications
  • Approx.3–5years’relevantexperience(mediorlevel)
  • Degreeinascientificorrelateddiscipline(Master’spreferred)
  • Experiencedworkingincross-functional,regulatedenvironments
Villes principales