QC Equipment ValidationGMPPh. EurEmpower softwareChange controlValidation deviationsCAPA’s, SOP’sGalenic formulationsChromatography and SpectrophotometryICPTitrationPSDChemical testsJob function:Expertise in HPLC/GC en grondstof analyse vereist (FTIR, raman, spectrofotometrie, refractometrie, densitometrie,...)Expertise in Ph.Eur, USP en JP pharmacopeal testing requirementsBereid om hands-on werk uit te voeren in kader van method implemenatie/validatieErvaring met Equipment validatie en data integrity requirements voor complex QC equipment en software bv HPLC, plate reader,User Requirements Specifications (URS).Installation qualification (IQ) en Operational qualification (OQ), Performance qualifications (PQ)Participeert in analytical method transfers en/of validaties: GAP assessments, SOP creatie en bijhorende trainings geven voor nieuwe methodsEen pluspunt indien er ervaring is met digitalisering van de werk flows (in kader van paperless lab transformatie)SkillsGMP experience in pharmaTechnical skills through experienceAnalytical thinkingTeamworkingResult orientedGood documentation and writing skills in English.ProfileMaster in chemistry with at least 5 years experience in GMPMinimum trained profile