Senior Quality Assurance Specialist

4 days ago


Køge, Køge Kommune, Denmark Magle Chemoswed Full time

Magle Biopolymers seeks an experienced QA specialist to join our team.

About the Role:
  • This position involves working cross-functionally with colleagues to develop processes and find better ways to work.
  • You will be assigned to various projects to represent the quality team, guaranteeing that our high-quality products are key to our success.
Key Responsibilities:
  • Able to work in a multisite environment, utilizing a single quality system for both Koge and Hårlev sites.
  • Review batch documentation, particularly in collaboration with the production environment, where experience in biopolymers is highly beneficial.
  • 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, where experience in this area is advantageous.
  • Manage changes, deviations, and complaints.
  • Offer customer support and collaborate with the team during customer and authority audits.
  • Support the team in evaluating suppliers and participate in customer and regulatory inspections.
  • Contribute to risk assessments and provide quality assurance across various tasks.
Requirements:
  • At least 5 years of experience in Quality work.
  • University degree in chemistry, pharmaceuticals, or an equivalent engineering discipline.
  • Previous work experience in pharmaceutical or Medical Device operations according to GMP part II and ISO 13485.
  • Able to handle challenges and willing to take calculated risks.
  • Lead by example, partner with production peers, and demonstrate a growth mindset.
  • Excellent proficiency in both Danish and English, spoken and written.
  • Familiarity with Microsoft Office and electronic/paper Quality Management systems.


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