Head of Quality hos Specific Pharma A/S
4 weeks ago
Om stillingen
Vi søger en erfaren og kompetent kvalitetschef til at lede vores QA-afdeling og fungere som firmaets QP og RP. Som Head of Quality vil du have en central rolle med stor indflydelse på kvalitetsudviklingen og forretningen generelt.
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
- Ett udfordrende og alsidigt job i en virksomhed i vækst med kort fra idé til handling.
- Ett 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 www.specificpharma.com.
Grib chancen for at blive en del af et dynamisk team og gøre en reel forskel i patientpleje
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