Head of Quality hos Specific Pharma A/S

4 weeks ago


Copenhagen, Copenhagen, Denmark Nomeco AS Full time

Om jobbet
Er du en dedikeret og resultatorienteret farmaceut, der søger en udfordrende rolle med stor indflydelse på kvalitetsudviklingen og forretningen generelt? Så er dette jobet for dig Som Head of Quality hos Specific Pharma A/S vil du være ansvarlig for at sikre, at vores QA-afdeling lever op til myndighedernes krav på alle kvalitetsrelaterede områder. Du vil 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.

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



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