Validation Specialist

4 weeks ago

Copenhagen, Copenhagen, Denmark Nomeco AS Full time

Om jobbet:

Som Validation Engineer i Nomeco A/S bliver du en del af vores valideringsteam med 10 ansatte, der håndterer kvalificering, validering og vedligehold af valideret stand for Nomecos kritiske infrastruktur, nøgleudstyr og IT-systemer.

Primære arbejdsopgaver:

  • Temperatur- og fugt-mapping af medicinallagre herunder ambient/køl/frost
  • Validering/kvalificering i henhold til Nomecos valideringsstrategi – herunder bl.a. valideringsplaner, kravspecifikationer, IQ, OQ, PQ samt risikovurdering
  • Ansvarlig for håndtering af afvigelser samt implementering af korrigerende handlinger
  • Ansvarlig for håndtering af ændringssager (Change Control)
  • Deltage i kundeaudits og myndighedsinspektioner
  • Samarbejde med QA-afdelingen om udførelse og udvikling af valideringsprocesser.
  • Vedligeholdelse og opdatering af SOP'er i vores Quality Management System (QMS) i samarbejde med øvrige medarbejdere i teknisk afdeling

Kvalifikationer:

  • Erfaring med eller kendskab til validering af udstyr og temperatur-mapping af faciliteter
  • Flair og interesse for udarbejdelse af kvalificerings- og valideringsdokumentation
  • Behersker både skriftlig og mundtlig engelsk og dansk på højt niveau

Som kandidat har du:

På det personlige plan har du et stærkt kundefokus og er altid optaget af at skabe værdi for forretningen. Du er en åben og positiv holdspiller med en systematisk, struktureret og grundig arbejdsmetode, der sikrer høj kvalitet til tiden. Du er udadvendt og serviceminded, og dine kvalifikationer og kompetencer inden for kvalificering og validering gør dig til en værdifuld sparrings- og samarbejdspartner.

For at få succes i jobbet skal du være proaktiv og have lyst til både at arbejde selvstændigt og på tværs af virksomheden. Du vil være med til at sikre, at øvrige afdelinger bliver involveret og engageret.

Det kan du forvente af Nomeco:

Du kan se frem til et uformelt og positivt arbejdsmiljø med kompetente og erfarne kolleger. Her får du masser af ansvar og rig mulighed for at definere og præge udviklingen i Nomeco.

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