Validation Expert

Kaiseraugst , Argovia, Switzerland

Type: n/a

Category: IT & Internet & Media

Requirements: English
Company: Randstad
Region: Kaiseraugst , Argovia

Jobdescription

Forourclient,aleadingpharmaceuticalcompanyinSwitzerland,wearelookingforaValidationExpert.

GeneralInformation:

• Startdate:ASAP
• Lateststartdate:01.09.2025
• Duration:unlimited
• Workplace:Kaiseraugst
• Workload:100%
• Team:20people
• Department:EngineeringScienceandTechnology(MMMCG)
• Workinghours:Standard
• On-callduty:Yes,throughouttheyear

Aboutthejob:

TheCenterofExcellenceCleaningValidationisresponsibleforscientificallydemonstratingthatthecleaningprocessofproductcontactproductionequipmentcanremoveallresiduestoensurethatnocross-contaminationoccurs.Validationisbasedontoxicologicaldata,sampling,andanalysisofsamplesinourlaboratoriesusingtechniquessuchasHPLC,ELISA,TOC,andMS.Thetraceanalysisusedisbothdevelopedandvalidatedin-house.OurclientscustomersspanallvaluestreamsinKaiseraugst,BaselBiotech,andpartsoftheIMPsector.AttheCleaningValidationCompetenceCenter,youhavenumerousopportunitiesforfurthertraining,aswehaveclosetiestopharmaceuticalproductionandarealsoacenterofexcellencefortraceanalysis.

Tasks&responsibilities:

• Collaborationwithinternalandexternalinterfaces(especiallylaboratoriesandvaluestreams),practicalimplementationanddocumentation ofallcleaningvalidationsampletrainsintheplants
• Sampling,samplepreparation,compilation,evaluationanddocumentationoftheresultsofthecleaningvalidationsampletrainscarriedout
• Creating/maintainingplans,reports,sampletrainprotocolsandSOPs
• Ensuringtimelycleaningvalidationactivitiesincompliancewithall GMPrequirementsandprocesses
• EnsuringthatcustomerrequirementsinproductionaremetinrelationtotheRV
• Riskassessmentsonthesubjectofcleaning
• ADCmonitoring,spillandsmallscalestudies,cleaningassessments
• Launches/techtransfersintheareaof??cleaningvalidations
• Troubleshootingincleaning-relatedproductionprocesses,conductingrootcauseanalyses,creatingproductqualityimpactassessments
• DOCSPOC,SMEforPQSdocuments
• Supportingsuggestionsforimprovementandprocessoptimizations
• CompliancewithSGUguidelines
• Supportingteamspiritandteamworkforindependentwork
• Ensuringasufficientflowofinformationwithintheteamandwithinterfaces

MustHaves:

• Min.completedvocationaltraining,universitydegreepreferred
• Min.2yearsofpracticalprofessionalexperienceintheareaofcleaningvalidationwithinapharmaceuticalproduction,particularlyinhandlingsamples
• Min.2yearsofprofessionalexperienceinaGMPregulatedworkingenvironment
• Experienceininterfacecommunication
• Interestinanalytics
• Willingnesstoconstantlydevelopfurtherandtakeonnewtasks
• AhighTeamplayer
• Agileandcreativemindset
• Flexibility,agilityandthewilltoimplementaleanculture
• GoodEnglish&fluentGermanskills

Nicetohaves:

• EVAL

Nextsteps

• Interviews:1.Virtual,2.Onsite

Soundsinteresting?Applynow - werelookingforwardtoreceivingyourapplications!

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