QP (qualified person)/Kvalitetsmedarbejder

1 week ago

Odense, Denmark Region Syddanmark Full time
QP (qualified person)/Kvalitetsmedarbejder

Klinisk Immunologisk Afdeling, OUH Odense søger en QP(qualified person)/kvalitetsmedarbejder i afdelingens kvalitetsafsnit pr. 1. marts 2025 eller efter aftale.

Klinisk Immunologisk afdeling (KIA) søger en velstruktureret akademisk medarbejder med interesse for kvalitetsarbejde og –udvikling. Opgaven bliver bl.a. at forberede myndighedsgodkendelse (§39-godkendelse) af facilitet til produktion af ATMP (Advanced Therapy Medicinal Products), deltage i udarbejdelsen af dokumentation mhp. ansøgning om tilladelse til forsøg med cellulær terapi samt fungere som QP (qualified person) ved frigivelse af cellulære produkter til kliniske forsøg.

Stillingen

Afdelingen har et program mhp. udvikling og produktion af Advanced Therapy Medicinal Products (ATMP), konkret CAR T-celler til kræftbehandling. Med henblik herpå er indrettet og valideret renrum i klasse AiB, og fremstilling af de cellulære produkter og metoder til kvalitetskontrol heraf er validerede. Næste skridt, som er umiddelbart forestående, er indsendelse af ansøgning til Lægemiddelstyrelsen om godkendelse af facilitet og fremstilling/frigivelse af de cellulære produkter til kliniske forsøg. Udarbejdelse af IMPD (Investigational Medicinal Product Dossier) og anden nødvendig dokumentation er i sidste fase. Du får en koordinerende rolle i denne proces, ligesom det forventes, at du kan fungere som QP ved frigivelse af de fremstillede produkter.

Du bliver en del af kvalitetsafdelingen, med reference til afdelingens kvalitetsleder. Kvalitetsafdelingen har det overordnede ansvar for udvikling og vedligeholdelse af afdelingens elektroniske kvalitetsledelsessystem (QMS) og supporterer alle afsnit i forbindelse med dette. Kvalitetsafdelingen har ansvaret for at gældende lovgivning og regler til enhver tid er implementeret i afdelingens generelle instruktioner. Kvalitetsafdelingen samarbejder bredt med alle afsnit i afdelingen, alle klinisk immunologiske afdelinger og blodbanker i Region Syddanmark, samt udvalgte afdelinger på OUH. Kvalitetsafdelingen har en koordinerende og deltagende rolle i forbindelse med interne- og eksterne audits i hele regionen. Du vil foruden opgaverne relateret til ATMP blive inddraget i løsning af andre opgaver på kvalitetsafdelingens område.

Primære arbejdsopgaver:

  • Forberedelse af dokumentation til ansøgning om fremstillertilladelse og godkendelse af facilitet (begge under §39)
  • Udarbejdelse af IMPD
  • Øvrige opgaver i kvalitetsafdelingen, fx udarbejdelse af instruktioner, afvigelseshåndtering, deltagelse i interne og eksterne audits

Minimumkrav:

  • Du er cand.pharm., cand.scient. eller har anden relevant videregående uddannelse
  • Du har fungeret som QP eller har fornøden baggrund for at kunne dette
  • Du har praktisk erfaring med kvalitetsarbejde fra laboratorie- eller produktionsvirksomhed
  • Du har erfaring inden for GMP, gerne fra farmaceutisk industri
  • Du evner at indgå i et tværfagligt samarbejde med forskellige faggrupper

Som person er du en dygtig kommunikator og sætter pris på dialog og samarbejde. Du trives i en hverdag, der kan være præget af rutineopgaver, men samtidig er i konstant udvikling og ofte kræver, at du sætter dig ind i nye områder. Du motiveres af skarpe deadlines, uden at gå på kompromis med kvaliteten og samarbejdet.

Vi tilbyder:

  • en attraktiv arbejdsplads i konstant udvikling
  • mulighed for faglig og personlig udvikling
  • et højt fagligt niveau

Om afdelingen:

Klinisk Immunologisk Afdeling (KIA) består af blodbanken, vævscenteret, laboratorium for celleterapi samt en række specialiserede laboratorier inden for blodtypeserologi, autoimmune sygdomme, molekylærbiologi, HIV og hepatitis, samt leukocytrelaterede sygdomme. Vi er en arbejdsplads med et aktivt uddannelses-, forsknings- og udviklingsmiljø. Afdelingen beskæftiger mange forskellige faggrupper, bl.a. læger, bioanalytikere, laboranter, paramedicinere, medicinstuderende, sekretærer, sygeplejersker samt cand. scient´er.

Yderligere information:

Stillingen er på fuld tid. Løn og ansættelsesforhold i henhold til overenskomst mellem Regionernes Lønnings- og Takstnævn og forhandlingsberettiget organisation.

OUH er en røgfri arbejdsplads. Det er ikke tilladt for ansatte på OUH at ryge i arbejdstiden og på OUHs matrikler. Røgfriheden er gældende for alle med en ansættelsestilknytning til OUH.

Ansættelsessamtaler:

Ansættelsessamtaler afholdes på KIA, OUH den 21. januar 2025.

#J-18808-Ljbffr

  • Kvalitetsmedarbejder til ATMP-udvikling

    6 days ago

    Odense, Odense Kommune, Denmark Region Syddanmark Full time

    Få en attraktiv arbejdsplads i konstant udvikling hos Klinisk Immunologisk Afdeling i Region Syddanmark!Om stillingenI forbindelse med udviklingen af Advanced Therapy Medicinal Products (ATMP), konkret CAR T-celler til kræftbehandling, søger vi en erfaren kvalitetsmedarbejder til at støtte afdelingens kvalitetsafsnit.Du vil være ansvarlig for at...

  • Kvalitetsmedarbejder til udvikling af Avancerede Terapeutiske Medicinske Produkter

    3 days ago

    Odense, Odense Kommune, Denmark Region Syddanmark Full time

    Jobbeskrivelse:I Region Syddanmark søger vi en erfaren kvalitetsmedarbejder til at støtte afdelingens arbejde med udvikling og produktion af avancerede terapeutiske medicinske produkter (ATMP).Opgaver:Forberedelse af dokumentation til ansøgning om fremstillertilladelse og godkendelse af facilitet.Udarbejdelse af IMPD.Øvrige opgaver i kvalitetsafdelingen,...

  • Klinisk Immunologisk Afdeling

    3 days ago

    Odense, Denmark Region Syddanmark Full time

    QP (qualified person)/Kvalitetsmedarbejder Klinisk Immunologisk Afdeling, OUH Odense søger en QP(qualified person)/kvalitetsmedarbejder i afdelingens kvalitetsafsnit pr. 1. marts 2025 eller efter aftale. Klinisk Immunologisk afdeling (KIA) søger en velstruktureret akademisk medarbejder med interesse for kvalitetsarbejde og –udvikling. Opgaven bliver...

  • Postdoctoral Researcher in Patient-Centered Communication

    7 days ago

    Odense, Odense Kommune, Denmark Hs Mittweida Full time

    Are you a motivated and experienced researcher looking to advance your career in patient-centered communication?We are seeking a highly qualified postdoctoral researcher to join our team at the Center for Research in Patient Communication, Department of Clinical Research, University of Southern Denmark.Job DescriptionThe position involves conducting research...

  • Robotics Systems Development Assistant

    3 weeks ago

    Odense, Odense Kommune, Denmark Syddansk Universitet Full time

    We are seeking a highly motivated and skilled student worker to assist in the development and operation of robotic systems at Syddansk Universitet.The ideal candidate will be enrolled as a student at SDU and possess prior knowledge about programming, modeling, and/or simulation. Key responsibilities include commissioning robotic components and programming...

  • Postdoc positions in Quantum Field Theory

    1 month ago

    Odense, Denmark Hs Mittweida Full time

    The Quantum Field Theory group of Professor Francesco Sannino at the Quantum Theory Center (QTC) hosted by the Department of Mathematics and Computer Science (IMADA) and the Danish Institute for Advanced Study of the University of Southern Denmark invites applications for two Post Doc positions. Outstanding candidates should have a PhD in theoretical...

  • Student worker position to the development and operation of robotic systems

    2 months ago

    Odense, Denmark Syddansk Universitet Full time

    Student Worker Position to the Development and Operation of Robotic Systems SDU Center of Large Structure Production (LSP) hereby invites applicants for an open position as student assistant in relation to the development and operation of robotic systems. The preferred applicant studies Robotics or a related field and has prior knowledge about programming,...

  • Postdoc in Generalized Symmetries and Their Applications to Quantum Matter

    4 weeks ago

    Odense, Denmark Hs Mittweida Full time

    The Centre for Quantum Mathematics (QM) at the Department of Mathematics and Computer Science, University of Southern Denmark (SDU) invites applications for a 1-year position as Postdoctoral Fellow in the group of Asst. Prof. Apoorv Tiwari with possibility of extension. We seek a postdoc with expertise in the field of generalized symmetries and their...

  • SDU Communications Department Student Assistant Opportunity

    1 month ago

    Odense, Odense Kommune, Denmark Syddansk Universitet (SDU) Full time

    About the PositionWe are seeking a highly motivated and proactive student assistant to join our team at Syddansk Universitet (SDU)\'s Faculty of Business. This is an excellent opportunity for students looking to gain valuable work experience while pursuing their studies.Job DescriptionThe successful candidate will be responsible for various tasks within the...

  • Energy Informatics Software Developer Assistant

    2 weeks ago

    Odense, Odense Kommune, Denmark Hs Mittweida Full time

    Job DescriptionWe are looking for a talented student to join our team as an Energy Informatics Software Developer Assistant.About UsOur company, SDU Center for Energy Informatics, is an interdisciplinary research and innovation center with a global outlook. Our mission is to contribute to the global transition towards a reliable, sustainable, low-carbon...

  • Senior Research Scientist in Aquatic Ecology and Environmental Modeling

    3 days ago

    Odense, Odense Kommune, Denmark Syddansk Universitet (SDU) Full time

    The Department of Biology at the University of Southern Denmark (SDU) invites applications for a position as a senior research scientist in aquatic ecology and environmental modeling. Job DescriptionWe seek an expert in marine ecology with excellent scientific and teaching achievements, who will contribute to our research group focused on marine environments...

  • Research Fellow in Quantum Field Theory and Symmetry Applications

    4 weeks ago

    Odense, Odense Kommune, Denmark Hs Mittweida Full time

    The Centre for Quantum Mathematics (QM) at the Department of Mathematics and Computer Science, University of Southern Denmark invites applications for a 1-year position as Postdoctoral Fellow in the group of Asst. Prof. Apoorv Tiwari with possibility of extension.We seek a postdoc with expertise in generalized symmetries and their applications in quantum...

  • PhD Researcher in Motor Control and Biomechanics of Voice Production

    3 weeks ago

    Odense, Odense Kommune, Denmark Syddansk Universitet (SDU) Full time

    About UsSyddansk Universitet (SDU) is a leading research institution with a strong focus on interdisciplinary collaboration. Our department of biology is committed to advancing knowledge in the fields of neuroscience, bioacoustics, and biomechanics.Salary and BenefitsThe successful candidate will receive a competitive salary of approximately $60,000 per...

  • Robotics Surgery Specialist

    4 weeks ago

    Odense, Odense Kommune, Denmark Intuitive Full time

    Job Summary:The Intuitive Clinical Sales Associate will play a pivotal role in maximizing the utilization of installed da Vinci Surgical Systems.About the Role:Implement a clinical sales strategy defined by the da Vinci Clinical Sales Manager to drive the adoption and utilization of the da Vinci Surgical System across core indications for the region.Become...

  • PhD Position in Applied Mathematics

    4 weeks ago

    Odense, Denmark Hs Mittweida Full time

    The Department of Mathematics and Computer Science at the University of Southern Denmark offers a full-time PhD position in the field of stochastic differential equations. The topic of the PhD project will be in the area of numerical analysis of stochastic differential equations including optimal control and applications in economy. The successful candidate...

  • Student helper at SDU Center for Energy Informatics

    2 weeks ago

    Odense, Denmark Hs Mittweida Full time

    Student helper at SDU Center for Energy Informatics SDU Center for Energy Informatics is looking for a new student helper. Are you an engineering student who has a programming background, looking for practical experience in developing interactive tools that can solve scientific and practical challenges? Responsibilities The main task is to develop an...

  • Numerical Analysis Research Fellow in Mathematics

    4 weeks ago

    Odense, Odense Kommune, Denmark Hs Mittweida Full time

    Company OverviewThe Department of Mathematics and Computer Science at the University of Southern Denmark offers a research-oriented environment with state-of-the-art facilities and a strong tradition for collaboration across departments and faculties.Salary and BenefitsAs a PhD Research Fellow, you will be employed in accordance with the agreement on...

  • Professor in Clinical Microbiology

    4 months ago

    Odense, Denmark Syddansk Universitet (SDU) Full time

    A position as professor in Clinical Microbiology (75%) and as a molecular biologist in clinical microbiology (25%) is vacant as soon as possible at the Research unit of Clinical Microbiology, Department of Clinical Research, University of Southern Denmark and at the Department of Clinical Microbiology, Odense University Hospital, respectively. The posts are...

  • Postdoc for project Wellbeing and Virtual Worlds

    4 months ago

    Odense, Denmark Syddansk Universitet (SDU) Full time

    The Department of Design, Media and Educational Science (Philosophy) invites applications for a 2-year postdoc position on the topic of values and wellbeing in relation to digital technology. The position is part of the collaborative research project Wellbeing and Virtual Worlds, funded by the Independent Research Fund Denmark and is available from Dec. 1.,...

  • Postdoctoral Researcher in Translational Cancer Biology

    1 month ago

    Odense, Odense Kommune, Denmark Hs Mittweida Full time

    We are seeking a highly motivated and experienced postdoctoral researcher to join our translational cancer research team at the Department of Biochemistry and Molecular Biology, SDU. The successful candidate will lead one of three translational cancer projects, focusing on uncovering the molecular mechanisms behind cellular senescence and its role in cancer...