About this opportunity
MSI Pharma lists this Digital Quality Lead opportunity in town of belgium, Wisconsin. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.