Highly Skilled Quality Assurance Professional

6 days ago


Køge, Køge Kommune, Denmark Magle Chemoswed Full time

We are Magle Biopolymers, a leading producer of APIs, Medical Devices, and technical-grade pharmaceutical materials. Our goal is to bring life-changing healthcare innovations to patients worldwide.

As a QA Specialist at Magle Biopolymers, you will play a crucial role in ensuring the quality of our products. You will be assigned to different projects to represent the quality team, enabling us to achieve our mission.

About the Role:
  • This is a full-time position based at our offices in Koge and Hårlev.
  • You will work multisite, with one quality system for both sites.
Key Responsibilities:
  • Review batch documentation, collaborating closely with production environment.
  • Provide flexible support to Deviations, Change Control, and CAPA processes.
  • QA writing, review, and approval of Standard Operating Procedures (SOPs).
  • Participate in improvements and qualification/validation processes.
  • Manage changes, deviations, and complaints.
  • Provide customer support and participate in audits.
  • Support supplier qualification and evaluation.
  • Participate in customer and regulatory inspections.

The ideal candidate will have experience from Quality work for 5 years or more, a university degree in chemistry, pharmaceuticals, or an equivalent engineering discipline, and previous work experience in pharmaceutical or Medical Device operations according to GMP part II and ISO 13485.

We offer a competitive salary between $80,000-$110,000 per year, depending on qualifications and experience. Additionally, we provide opportunities for development in various areas of QA, as well as a dynamic and supportive work environment.



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