Validation Engineer

5 days ago

København, Denmark Nomeco AS Full time

Er du passioneret omkring procesoptimering og validering? Så kan du får en nøglerolle i at sikre den validerede tilstand af vores faciliteter og udstyr i Nomeco

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.

Om jobbet:
Som valideringsspecialist 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.

Som vores nye kollega i valideringsteamet får du et udfordrende og selvstændigt job i en dynamisk virksomhed, med mulighed for at komme vidt omkring inden for området kvalificering og validering. Du får rig mulighed for at præge din stilling i teamet, hvor du i et tværfagligt samarbejde skal varetage følgende opgaver:

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:
Du er formentlig ingeniør, kvalitet eller IT uddannet, eller også har du erfaring med ovenstående arbejdsopgaver fra et lignende job.

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.

Du behersker både skriftlig og mundtlig engelsk på højt niveau

Som kandidat har du:
På det personlige plan har du et stærkt kundefokus og har altid fokus på at skabe værdi for forretningen. Du er en åben og positiv holdspiller, har en systematisk, struktureret og grundig metodisk arbejdsform med fokus på at levere høj kvalitet til tiden. Du er udadvendt og serviceminded. Dine kvalifikationer og kompetencer inden for kvalificering og validering gør dig til en god sparrings- og samarbejdspartner.

For at få succes i jobbet, skal du være proaktiv og have lyst til både at arbejde selvstændigt, men også til at arbejde ”på tværs” i virksomheden og være med til at sikre øvrige afdelingers involvering og engagering.

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

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