Head of Quality hos Specific Pharma A/S

5 days ago


Copenhagen, Copenhagen, Denmark Nomeco AS Full time

Nomeco
Head of Quality hos Specific Pharma A/S

Er du passioneret omkring at gøre en forskel for patienter og ønsker at anvende dine farmaceutiske færdigheder fuldt ud? Specific Pharma A/S tilbyder en unik karrieremulighed som Head of Quality, hvor du kan lede vores QA-afdeling og fungere som firmaets QP og RP.

Om Specific Pharma
Specific Pharma er en af de få virksomheder i Nordeuropa, der specialiserer sig i at source og håndtere lægemidler til patienter, som ikke kan behandles tilstrækkeligt med allerede markedsførte lægemidler, også kaldet IRS lægemidler.

Vi har desuden en unik position som leverandør af Clinical Trial Supply Management, der dækker alle nødvendige ydelser for opbevaring og distribution af forsøgsmedicin til kliniske studier i både Danmark og udlandet.

Din Rolle
Som Head of Quality og RP hos Specific Pharma vil du få en central rolle med stor indflydelse på kvalitetsudviklingen og forretningen generelt. Du vil sikre, at Specific Pharma altid lever op til myndighedernes krav på alle kvalitetsrelaterede områder. Som QP vil du have ansvar for teknisk frigivelse af lægemidler importeret fra lande uden for EU/EØS samt godkendelse af IMP og non-IMP pakkeopgaver i vores Clinical Trial Supply.

Du bliver en del af firmaets ledelsesgruppe og får ledelsesansvar for tre medarbejdere og får direkte reference til den administrerende direktør.

Dine Ansvarsområder

  • QP teknisk frigivelse af lægemidler importeret fra lande uden for EU/EØS
  • QP-godkendelse af non-IMP pakkeopgaver i CTSM samt frigivelse af CTSM pakkeopgaver
  • Myndighedsinspektioner og kundeaudits
  • Udvikling og vedligeholdelse af QMS-system inkl. risikovurdering og styring
  • Træning af medarbejdere i forhold til deres jobbeskrivelser
  • Håndtering af afvigelser, reklamationer, CAPA og Change Control
  • Leverandør- og kundekvalificeringer
  • Interne og eksterne audits
  • Håndtering af tilbagekaldelser
  • Inspiration, motivation og videreudvikling af dine medarbejdere

Din Profil

  • Uddannet farmaceut med kvalifikationer til at varetage rollen som Qualified Person (QP) for teknisk frigivelse af lægemidler importeret fra lande uden for EU/EØS samt GMP pakke- og etiketteringsopgaver.
  • Stor ansvarsfølelse og evne til at arbejde målrettet, systematisk og selvstændigt.
  • Forretningsorienteret og pragmatisk tilgang til kvalitetsområdet med fokus på muligheder frem for begrænsninger.
  • Evne til at formidle GMP/GDP-emner klart og positivt til kolleger, samarbejdspartnere og myndigheder.
  • Ledelseserfaring og evne til at motivere og udvikle dit team.
  • Evne til at bevare overblikket i et omskifteligt og travlt miljø.

Vi Tilbyder

  • Et udfordrende og alsidigt job i en virksomhed i vækst med kort fra idé til handling.
  • Et kompetent, uhøjtideligt og professionelt arbejdsmiljø.
  • Løn efter kvalifikationer og gode ansættelsesvilkår.

Kontakt og Ansøgning
For mere information om stillingen, kontakt adm. direktør Uffe Kåre Jensen på 60346540. Vi indkalder løbende til samtale. Tiltrædelse hurtigst muligt.

Specific Pharma er et datterselskab til Nomeco, og du vil få din daglige gang i vores hovedkvarter på Borgmester Christiansens Gade 40, 2450 København SV. Vi er 37 dedikerede medarbejdere, der hver dag arbejder for at gøre en forskel for den enkelte patient. Læs mere om os på

Grib chancen for at blive en del af et dynamisk team og gøre en reel forskel i patientpleje

Ansøgningsfrist:
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