Digital Specialist

Il y a 6 heures

belgium be MSI Pharma Temps plein

DigitalSpecialist–AnalyticalDevelopment Location: Brainel'Alleud,BelgiumEngagementStatus: FreelancepositionuntilendofDecember2026(strongpotentialextension)Overview WearesupportingalargepharmaceuticalorganisationwhoarelookingforaDigitalSpecialist– AnalyticalDevelopmenttosupportamajordigitaltransformationwithinanAnalyticalDevelopmentSciencesenvironment,partofCMC.Thisrolesitsattheintersectionofanalyticallaboratories,digitalsolutions,andregulatorycompliance,supportinganalyticalmethoddevelopmentandstabilityactivitiesfromearlyclinicalphasesthroughlifecyclemanagement.TheenvironmentspansbothGSPandGMP.Thepositionisembeddedinalarge-scaledigitaltransformationprogramdrivenbyFDAdigitalsubmissionrequirements,withastrongfocusonstructured,traceable,andregulatory‑readyanalyticaldata.KeyResponsibilities

  • Actasabridgebetweenanalyticaldevelopmentscientists,quality,IT,anddigitalteams
  • Analyzeexistinglaboratoryprocessesanddataflows
  • Performend‑to‑endprocessanddatamapping
  • Translatescientificandbusinessprocessesintostructureddatarequirements
  • ChallengeITanddigitalsolutionsfromabusinessanduserperspective
  • Ensurecompliancebydesign(GxP,ALCOA+)
  • Supportdeploymentofdigitaltoolsandassistendusers
  • Facilitatediscussionsbetweenstakeholdersanddrivepragmatic,alignedsolutions
Requirements
  • 3–8yearsofprofessionalexperience
  • Provenexperienceindatamapping,dataflowdesign,businessanalysis,ordataanalysis
  • StrongunderstandingofGxPenvironmentsandALCOA+principles
  • ExperienceworkingattheinterfacebetweenbusinessandIT
  • FluentEnglish(mandatory)
HardSkills
  • Translatinglaboratoryworkflowsintostructureddigitalanddatarequirements
  • Processmappinganddataflowdesign
  • Regulatoryandcompliance‑drivendigitalsolutions
  • Experiencewithregulatedenvironments(GxP)
  • Nicetohave:
  • CMC,AnalyticalDevelopment,orQClaboratoryexposure
  • ELN(e.g.IDBS),LIMS(e.g.LabWare),PowerBI
  • Datagovernanceordataengineeringconcepts
  • Experienceindigitaltransformationprograms
SoftSkills
  • Strongstakeholdermanagementandcommunicationskills
  • Business‑orientedmindsetwiththeabilitytochallengeconstructively
  • Abilitytostructurecomplexdiscussionsandaligndiversestakeholders
  • Pragmatic,solution‑drivenapproach
  • Comfortableworkingincross‑functional,internationalenvironments