IT Validation Engineer

3 weeks ago


Copenhagen, Copenhagen, Denmark Nomeco AS Full time
Om jobbet:

Som valideringsspecialist i Nomeco bliver du en del af vores team med 8 ansatte, der håndterer kvalificering, validering og vedligehold af valideret stand for Nomecos kritiske infrastruktur, nøgleudstyr og IT-systemer.

Udfordringer og muligheder:
  • Kvalificering og validering af infrastruktur, udstyr og gerne også IT-systemer, i henhold til Nomecos procedurer, herunder udarbejdelse af VP, URS, risikovurdering, IQ/OQ/PQ, samt gennemførelse og afrapportering af test.
  • Deltagelse i projekter som valideringsekspert ved udarbejdelse af URS etc., i tæt samarbejde med bl.a. logistikteamet og andre afdelinger i Nomeco.
  • Ift. IT-validering, vil du være en aktiv sparringspartner for systemejere af IT-systemer, bl.a. ved behandling/root-cause analyse af afvigelser, ændringssager, samt indkøb af nye systemer
  • Deltage i klient audit og myndighedsinspektioner.
  • Samarbejde med QA-afdelingen om udførelse og udvikling af valideringsprocesser.
Kvalifikationer:
  • Erfaring med validering af infrastruktur og udstyr for den farmaceutiske industri (GMP/GDP), herunder udarbejdelse og gennemførelse af dette.
  • Har praktisk erfaring med risikovurderinger (FMEA), ændringssager (CR) og afvigelser (NC/VNC)
  • Gerne erfaring med IT-validering inden for den farmaceutiske industri (GMP/ GDP), herunder udarbejdelse og gennemførelse af dette.
  • Kendskab til myndighedskrav til kvalificering og validering, herunder.: EU GDP, EU GMP Annex 15, EU GMP Annex 11 og GAMP 5.
  • Har interesse og flair for god test- og dokumentationspraksis og sætter dig let ind i guidelines og retningslinjer.
Om os:

Nomeco er den foretrukne lægemiddelgrossist for apoteker og hospitaler i Danmark– ligesom vi er lægemiddelindustriens foretrukne strategiske logistikpartner. Vi er specialister i sundhedslogistik, og sikrer, at danskerne altid har rettidig adgang til lægemidler. Nomeco udvikler sig i tæt dialog med marked og myndigheder, og udviklingen sker på et solidt fundament af viden og værdier.



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