QA Senior Specialist for QC

1 day ago


Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

Vi redder menneskeliv på verdensplan; Vil du være med?
Hvis du brænder for at gøre en forskel og sikre kvaliteten af livsvigtige produkter, så er denne stilling måske noget for dig. Vi søger lige nu flere medarbejdere til vores afdeling. Som QA Senior Specialist i QA-afdelingen spiller du en afgørende rolle i vores mission og får mulighed for at bidrage til at redde liv på globalt plan.

Teamets ansvar og ambitioner
I QA er vi cirka 50 kollegaer fordelt på QA Facilities & QC, QA Operations og QA Compliance. Du bliver en del af QA Facilities & QC teamet, som har hovedansvaret for (i) QC, (ii) faciliteter og udstyr og (iii) IT. Vi søger flere QA Senior Specialister, som vil være ansvarlige for QC.

Du bliver ansvarlig for:

  • QA supporterer QC herunder OOS- og metodeundersøgelser
  • Godkendelse af GMP-dokumentation, afvigelser, CAPA og ændringssager for QC
  • QA godkende kvalificering af analyse udstyr
  • Godkendelse af Extractables & Leachables studier
  • Godkende stabilitetsstudier og metode valideringer
  • QA supporterer inden for GMP spørgsmål på tværs af virksomheden

Hvem er du?
Som person motiveres du af at løse faglige udfordringer. Du ser vidensdeling som en essentiel del af hverdagen og hjælper kollegaer, når der er behov.

Vi vægter en høj faglig standard og forventer, at du kan arbejde både i teams og selvstændigt, være struktureret og håndtere flere opgaver på én gang.

Vi forventer, at du har en relevant naturvidenskabelig uddannelse som ingeniør, cand.scient., cand.pharm. eller lignende med erfaring fra lægemiddelindustrien eller erfaringer indenfor QA, faciliter og udstyr.

Ideelt set har du:

  • Erfaring med GMP-dokumentation, -vurdering og -godkendelse.
  • Kendskab til kravene for at arbejde i en producerende GMP-virksomhed.
  • En omhyggelig, struktureret og ansvarlig tilgang til dit arbejde.
  • Stærke samarbejdsevner og fleksibilitet.
  • Gode formuleringsevner på både dansk og engelsk.

Vi tilbyder
Spændende arbejdsopgaver i en international virksomhed med høj faglighed og stort engagement. Du vil få et stort netværk af dygtige kollegaer i et miljø, hvor faglig sparring er en naturlig del af hverdagen. Du får en bred kontaktflade internt såvel som eksternt og en konstant udvikling af dit kvalitets-mindset i en virksomhed i rivende udvikling. Vi er centralt beliggende i København og har kontorpladser i Augusthus Woods tæt ved metrostationen DR Byen.

Er du interesseret?
Send os dit CV snarest muligt, da vi løbende indkalder kandidater til samtaler. I AJ Vaccines går vi ind for en inkluderende rekrutteringsproces, der er fair for alle ansøgere. Vi ser derfor helst, at du ikke vedlægger foto.

Vil du vide mere?
Har du spørgsmål eller brug for yderligere information, er du velkommen til at kontakte Head of QA Facilites & QC, Abdu Sahan på tlf. +45 25569399.

Afdeling: Artillerivej 5, København S

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