QA specialist for Outsourcing

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

Bagsværd

Are you seeking a dynamic and challenging role in an international environment? Are you a experienced professional or Specialist with expertise in GMP and especially aseptic manufacturing? Do you have passion for ensuring quality compliance in outsourced activities? Do you want to make a real impact on the lives of patients with diabetes and other chronic diseases? Our team is dedicated for providing a high level of QA support to the organization and making a difference for our patients and colleagues. You will find that you have rich opportunities to create great results and develop yourself, both on a professional and on a personal level. We implement individual development plans which support your growth and assist you in achieving your professional ambitions.
We can offer a great working environment with high level of team spirit as well as highly skilled, ambitious, and engaged colleagues. We ensure that there is a good work-life balance. We share an informal tone, and enjoy learning from each other, striving to deepen our understanding of a complex area.
The position
As a QA Specialist, you will play a pivotal role in the selection and assessment of CMOs, negotiation and implementation of Quality Agreements, and support of outsourced production activities. Your extensive QA and GMP knowledge will be leveraged to ensure product quality and compliance with cGMP and marketing authorizations. In this role, you will:
  • Provide GMP direction to outsourced manufacturing and support the implementation of new quality compliance measures in close collaboration with management
  • Facilitate critical cases (DV, CR, validation, etc.) in collaboration with line of Business (LoB) and GCM colleagues
  • Drive internal compliance projects to ensure standards for outsourced activities
  • Support CMOs in quality matters
  • Participate in audits/inspections as coach and follow-up on QA findings
  • Contribute to Process Groups, working groups, and projects related to QMS or your core area of expertise
  • Serve as a subject matter expert in GMP and quality matters
  • Deliver training in quality activities
  • The role requires up to 20-30 days of travel per year to primarily CMO locations outside of Denmark. If you´re seeking a role that will challenge and develop your professional and personal competences, this is the opportunity for you. Qualifications
    As the ideal candidate you have previous experience within quality assurance, and you have worked with suppliers in a global environment.
  • Pharmacist, Engineer or equivalent academic degree with minimum 6 years experience in a pharmaceutical organization
  • Expertise in API and intermediates production, Tablet production, Aseptic formulation and filling production activities and/or Assembly & Packaging and related validation requirements.
  • Up to date knowledge of pharmaceutical quality and GMP requirements for drug products, including audits, contract negotiation, validations, change control, NC handling, CAPA handling
  • Expertise in quality requirement for contract manufactured products and experience with outsourcing will be an advantage
  • Selfdriven and strong team player with excellent problem-solving and communication skills
  • Proactive and solution-oriented with a can-do attitude and strategic focus
  • Skilled communicator who can engage at all levels of the organization and make independent decisions
  • About the department
    GCM QA is responsible for quality assurance and quality support to outsourced production activities worldwide.
    GCM QA is a dynamic department consisting of 45 competent people divided into 4 teams with focus on either operations, projects or QA Support. You will be a strong player in the QA Support team together with 3 other QA specialists and QA professionals working with master data. The department is characterised by a high level of professionalism, flexibility, and cooperation. The primary role of our department is to deliver QA support and set direction for our global CMOs. We focus on good social relations and prioritise to make room for fun at work. We have weekly quizzes, and we strive to have daily workout sessions to ensure on-going well-being in the team.
    Working at Novo Nordisk
    At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth. Contact
    For further information, please contact Associate Manager Marianne Hjulgaard on +45 30 79 86 31 or QA Specialist Hans Juhl +45 30 79 54 12

    Deadline
    15th Marts 2023.

    We will review applications and perform interviews on an ongoing basis, so you are encouraged to apply as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation 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 Novo Nordisk 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 28.12.2022, 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

    • Øvrige i Frederiksberg C

      Fri kontakt
      Se https://www.digitaldisruptionmedia.com/jobs/piccolinepiccolo-sges-snarest
      • Øvrige
      • Frederiksberg C
      Få mere info
    • Restaurant Manager, Restaurant Ansvar at Scandic S...

      Fri kontakt
      Job Description. If you are ambitious, goal-oriented and not afraid to clear habitual thinking off the table, then we believe that you are our new Restaurant Manager for Restaurant Ansvar, Scandic Spectrum. We know that you take responsibility and have peace of mind with the full overview.
      • Øvrige
      • København
      Få mere info
    • Restaurant Manager til Restaurant Ansvar, Scandic ...

      Fri kontakt
      Er du ambitiøs, målrettet og ikke bange for at rydde vanetænkning af bordet, så tror vi på, at du er vores nye Restaurant Manager til Restaurant Ansvar, Scandic Spectrum. 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
    • Conference Host, fuldtid, Scandic Sluseholmen

      Fri kontakt
      Griber du mulighederne, har overblik og er god til at guide vores gæster, så tror vi på, at du er vores nye Conference Host på Scandic Slusenholmen. Vi ved, at du brænder for at gøre en forskel og har fokus på detaljerne. Og vi ved, at du får tingene til at ske og gerne sætter overliggeren lidt højere for at skabe en succes.
      • Øvrige
      • København
      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
    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
    21. oktober 2024 50
    20. oktober 2024 55
    19. oktober 2024 55
    18. oktober 2024 53
    17. oktober 2024 49
    16. oktober 2024 51
    15. oktober 2024 58
    14. oktober 2024 58
    13. oktober 2024 67
    12. oktober 2024 67
    11. oktober 2024 64
    10. oktober 2024 63
    9. oktober 2024 62
    8. oktober 2024 59
    7. oktober 2024 60