Quality Assurance Professional

1 day ago


Køge, Køge Kommune, Denmark Magle Chemoswed Full time

Job Summary

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This role involves working as a Quality Assurance Specialist at Magle Biopolymers. You will be responsible for ensuring that our high-quality products meet regulatory requirements and industry standards.

About the Job

  • As a QA Specialist, you will play an important role in the business, enabling us to bring life-changing healthcare innovations to patients.
  • You will be assigned to different projects to represent the quality team, ensuring that our high-quality products are key to our success.
  • You will work closely with production peers to develop processes and find better, more efficient ways to work.

Key Responsibilities:

  • Review batch documentation (in close collaboration with production environment).
  • Provide flexible and collaborative 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 with the team in both customer and authority audits.
  • Provide support within the team for qualification and evaluation of suppliers.
  • Participate in customer and regulatory inspections, investigations, and risk assessments.

Requirements

  • Experience from Quality work for 5 years or more.
  • 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 'learning by doing' and willing to act even if there is a risk of mistakes.
  • Lead by example, be a partner to production peers, be humble and open to learn and teach by doing.
  • You must be able to work independently and to speak up when changes need to be addressed.
  • Excellent proficiency in both Danish and English, spoken and written.
  • Experienced user of Microsoft Office and electronic/paper Quality Management systems.


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