Advanced QA Professional

Denne stilling er desværre ikke længere ledig.
Se alle ledige stillinger

Bagsværd

Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so, this position as QA Professional in Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA could be a unique opportunity for you!   The position  We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area. You will be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies. You will be a part of our development projects ensuring that raw materials for our products are used in clinical trials following the information provided to Health Authorities worldwide. Furthermore, you will - in close cooperation with your colleagues - identify and contribute to strengthening our production facilities´ compliance level if needed and act as a consultant for stakeholders. You will contribute to finding solutions for ad hoc questions, deviations, and challenges within cGMP compliance.   Your responsibilities:
  • Responsible for delivering best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product production for clinical trials. 
  • Challenge and approve documents in connection with raw materials and CMO shipping.
  • Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements.
  • Responsible for securing quality agreements with external suppliers.  
  • Qualifications
    To succeed in this role, you have:
  • MSc in Pharmaceutical Sciences, Engineering, Biochemistry or similar. 
  • Preferably 1-2 years experience within the pharmaceutical industry, specifially within quality or production.
  • Experience with GMP.
  • Experience working with raw materials for API production  would be hihgly beneficial.
  • Proficiency in English.
  • Proficiency in Danish is an advantage, but not a requirement.

  • The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues with a necessary and sufficient mindset, make decisions and follow-up on quality related problems. You are a self-driven and independent person with a high sense of responsibility and initiative who can prioritize your many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders – internally and externally. 
    About the department  CMC API QA is a department which employs 35 skilled and motivated colleagues in four teams, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials and the release of API for clinical trials. We also have the responsibility of releasing API from contract manufacturers across the globe. In the department, we value teamwork, diversity and humor very high, and we will make sure you, as a new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor.  Contact  For further information, please contact Associate Manager Caroline Benedicte Kjærulff Mathiesen at [xxxxx] or +[xxxxx].   Deadline
    30 October 2024. Note that applications will be reviewed on an ongoing basis and the position will be closed when we find the right candidate. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx], we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

    Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

    Arbejdsstedet er beliggende i Bagsværd.

    Jobbet er oprettet på vores service den 28.8.2024, men kan have været deaktiveret og genaktiveret igen.

    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Øvrige
    • Bagsværd

    Lignende jobs

    • Senior Associates og Managers til Transaction Advi...

      Fri kontakt
      Senior Associates og Managere til Transaction Advisory Service i København. Vi mærker en stigende efterspørgsel efter rådgivning i forbindelse med køb og salg af virksomheder, herunder finansiel due diligence. Derfor søger vi Senior Associates og Managere til vores TAS team på Østerbro.
      • Øvrige
      • København Ø
      Få mere info
    • Øvrige i Frederiksberg C

      Fri kontakt
      Se https://www.digitaldisruptionmedia.com/jobs/piccolinepiccolo-sges-snarest
      • Øvrige
      • Frederiksberg C
      Få mere info
    • Breakfast Manager, fuldtid, Scandic Webers

      Fri kontakt
      Er du ambitiøs, målrettet og ikke bange for at rydde vanetænkning af bordet, så tror vi på, at du er vores nye Breakfast Manager på Scandic Webers. Vi ved, at du ta’r ansvar og har ro i maven med det fulde overblik. Du er god til at organisere, købe ind, lede og dele din viden.
      • Øvrige
      • København
      Få mere info
    • Erfaren konsulent med politisk tæft til SMV & Ivær...

      Fri kontakt
      Leder du efter et sted, hvor du kan få en vigtig rolle med politikudvikling, kommunikation og politisk interessevaretagelse inden for erhvervspolitik? Så har vi jobbet her i teamet for ’SMV & Iværksætteri’. SMV’er og iværksættere udgør rygraden af dansk erhvervsliv. Deres succes er Danmarks succes.
      • Øvrige
      • København V
      Få mere info

    Statistik over udbudte jobs som øvrige i Bagsværd

    Herunder ser du udviklingen i udbudte øvrige i Bagsværd over tid. Bemærk at jobs der ikke har en bestemt geografi ikke er medtaget i tabellen. I den første kolonne ser du datoen. I den næste kolonne ser du det samlede antal øvrige.

    Se flere statistikker her:
    Statistik over udbudte øvrige i Bagsværd over tid

    Dato Alle jobs som øvrige
    21. november 2024 65
    20. november 2024 66
    19. november 2024 65
    18. november 2024 64
    17. november 2024 73
    16. november 2024 73
    15. november 2024 70
    14. november 2024 69
    13. november 2024 66
    12. november 2024 62
    11. november 2024 60
    10. november 2024 62
    9. november 2024 62
    8. november 2024 59
    7. november 2024 58
    6. november 2024 57
    5. november 2024 57
    4. november 2024 53
    3. november 2024 58
    2. november 2024 57
    1. november 2024 56
    31. oktober 2024 64
    30. oktober 2024 50
    29. oktober 2024 49
    28. oktober 2024 47
    27. oktober 2024 53
    26. oktober 2024 53
    25. oktober 2024 54
    24. oktober 2024 51
    23. oktober 2024 51
    22. oktober 2024 49