Digital Quality Lead
Il y a 1 jour
Belgique
MSI Pharma
Temps plein
80 000 € - 100 000 €/an
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Location:WalloonRegion(hybridworkingmodel)
Engagement:12-monthfreelanceengagement(ASAPstart)
Overview
Wearepartneredwithaglobalpharmaceuticalorganisationtosupportthebuild-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