Quality Coordinator within a production department

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Kalundborg

Unlock your potential at [xxxxx] by leading transformative quality initiatives that enhance compliance across multiple departments, while collaborating with passionate professionals in an innovative environment dedicated to making a difference. Join us in shaping the future of healthcare through a role that combines strategic oversight and hands-on problem-solving in a dynamic production setting.Your new role
This role focuses on fostering a high-level quality culture within your department and managing complex quality and compliance improvements from planning to implementation. You'll collaborate with various stakeholders across multiple departments to ensure successful delivery and maintain compliance within the quality coordination team.
Day-to-day your tasks will include:
  • Supporting your department (and CVP area) in ensuring the correct quality level in various production challenges such as DV (Deviation) handling or other quality/compliance challenges.
  • Assisting in scoping and prioritizing incoming compliance signals from various audits and inspections.
  • Manage and ensure plan adherence in planned and incoming compliance improvement/signals.
  • Identify trends and possibilities for improvements, that can reduce complexity and build quality and robustness into the processes
  • Prepare for internal audits and inspections.
  • Ensure change management when implementing improvements to GMP and QMS.
  • Prepare trend reports, quality oversight tools, Quality Management Review etc.
  • To succeed in this job, it is a prerequisite that you have a can-do attitude, are curious to understand, gain energy by interacting with many stakeholders and thrive in managing different tasks simultaneously.Your new department
    You will be reporting to the Department Manager and be a part of the management team of PPI (Degludec and Detemir production) in PP. However, the majority of your time will be spent on prioritizing and managing larger cross departmental compliance improvements/signals in close collaboration with the rest of the quality coordinator group in PP. The group consists of six (including you) highly dedicated and qualified persons with whom you will solve most of your cross-departmental tasks in collaboration with. We share an informal and relaxed tone and work purposefully to deliver the right level of quality of our products to the patients we serve every day.Your skills and qualifications
    The position requires a high degree of knowledge within working with compliance improvements in a GMP regulated environment and the ability to scope and deliver the best-possible solutions to new requirements from signals, inspections and audits.Furthermore:
  • You have minimum 5 years of experience with GMP from relevant position in the medical industry, complimented by the ability to manage complex projects.
  • You hold a master’s degree within chemistry, life sciences or another relevant field.
  • You have experience with most of the following processes: deviation handling, change requests and qualification/validation.
  • You are curious and able to see opportunities for compliance improvements. Independence is a prerequisite, as well as the ability to collaborate with various groups of employees with different backgrounds.
  • Previous experience with processes like columns, centrifuges, CIP or EM are an advantage.
  • You speak/write professionally English.
  • Working at [xxxxx]
    Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.What we offerThere is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.
    More information
    If you have any questions regarding the position, please feel free to contact Marianne Espenhain[xxxxx]or CVP Quality Coordinator Kiki Olsen[xxxxx]

    Deadline
    17 August 2025.
    Applications are reviewed on an ongoing basis.

    [xxxxx] is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.


    Information og data

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

    Arbejdsstedet er beliggende i Kalundborg.

    Jobbet er oprettet på vores service den 7.7.2025, 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
    • Kalundborg

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