Systems Validation Specialist

4 days ago

Dublin, Dublin City, Ireland Icon Full time

Systems Validation Specialist ICON plc is a world-leading healthcare intelligence and clinical research organization.
We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Bij ICON plc ben je niet enkel getuige van de toekomst van klinische geneesmiddelenontwikkeling.
Je maakt er deel van uit Heb je affiniteit met de medische wetenschap en werk je graag in een GMP/GCP/GLP omgeving?
Zoek je een uitdagende baan binnen het geneesmiddelenonderzoek en ben jij straks verantwoordelijk voor de validatie-activiteiten?
ICON breidt uit en is op zoek naar jou
Wat ga je doen? Als Systems Validation Specialist ben je verantwoordelijk voor het initieëren en organiseren van validatie-activiteiten binnen onze kliniek, klinisch chemisch laboratorium en apotheek (o.a.
cleanrooms) in Groningen.
Daarnaast ben je onderdeel van een internationaal team die ondersteuning biedt aan validatie-activiteiten in Nederland, Oost-Europa en de Verenigde Staten.
In deze rol ga je samenwerken met apothekers, IT en QA professionals en in sommige gevallen met project managers.
Je bent verantwoordelijk voor: Valideren/ kwalificeren van apparaten en computerized systems volgens de geldende ICON procedures.In- en externe partijen ondersteunen bij validatieprocessen of optreden als projectleider in validatieprocessen.Het schrijven van documenten ter ondersteuning van het validatie/ kwalificatie proces.Validatie documenten reviewen.Continu verbeteren van processen en kwaliteit.Kennis overbrengen aan in- en externe partijen over validatie.Het beantwoorden van vragen met betrekking tot regelgeving en ondersteuning bieden bij audits.Als Systems Validation Specialist werk je op onze locatie in Groningen.
Je werkt samen met collega's van ons laboratorium in Assen en op locaties buiten Nederland.
De werkzaamheden dienen uitgevoerd te worden conform GxP, GAMP en FDA regels.
Een combinatie van office-based (Groningen) en home-based is bespreekbaar.
Wat breng jij mee? Je hebt MBO Plus of HBO werk- en denkniveau.Goede kennis van validatie en in het bijzonder validatie van Computer Systemen.Je hebt kennis van GMP, GCP of GLP regelgeving.
Daarnaast is kennis m.b.t.
cleanrooms een pré.Je hebt affiniteit met techniek en IT systemen.Goede communicatieve vaardigheden, kwaliteits- en oplossingsgericht.Daarnaast kan je goed zelfstandig werken en je bent proactief.Goede beheersing van de Engelse taal in woord en geschrift.Wat hebben wij jou te bieden? Een uitdagende functie in een groeiend internationaal bedrijf bij ons locatie in Groningen.Goede aanvullende voorwaarden zoals deze zijn vastgelegd in onze eigen cao.Jaarlijks organiseren we (sportieve) activiteiten gericht op o.a.
teambuilding en gezelligheid.Een jaarcontract, met zicht op een vast dienstverband.
Het betreft een functie voor minimaal 32 uur per week.Veel aandacht voor je persoonlijke ontwikkeling en volop mogelijkheden om aan je carrière te werken (zoals doorgroeimogelijkheden, het volgen van trainingen en opleidingen).Wat doet ICON? In opdracht van farmaceutische bedrijven doet ICON wereldwijd wetenschappelijk onderzoek naar de werking van geneesmiddelen bij mensen.
In Nederland heeft ICON de divisie Early Clinical & Bioanalytical Services (IEB) met zo'n 750 medewerkers.
Hier wordt enerzijds klinisch- en anderzijds bioanalytisch onderzoek verricht.
Werken bij ICON betekent dat je werkt aan de ontwikkeling van de geneesmiddelen van de toekomst.
Het betekent ook werken aan jezelf en bijdragen aan de ontwikkeling en groei van ICON.
De ontwikkeling van onze mensen is het succes van onze organisatie.
Klaar voor een nieuwe uitdaging en wil je werken in onze kliniek? Reageren?
Laat cv en motivatie in 1 bestand achter

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