Senior QA Specialist

19 hours ago


Køge, Køge Kommune, Denmark Magle Chemoswed Full time

Job Overview

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Magle Biopolymers is seeking a highly experienced Quality Assurance Specialist to join their team. As a QA Specialist, you will play a critical role in ensuring the quality of our products meets regulatory requirements and industry standards.

About the Position

  • You will be responsible for reviewing batch documentation and providing support to Deviations, Change Control, and CAPA processes.
  • You will work closely with production peers to develop processes and find better, more efficient ways to work.
  • You will participate in improvements and qualification/validation processes, manage changes, deviations, and complaints, and provide customer support.

Responsibilities:

  • QA writing, review, and approval of Standard Operating Procedures (SOPs).
  • Participate in customer and regulatory inspections, investigations, and risk assessments.
  • Provide support within the team for qualification and evaluation of suppliers.
  • Work collaboratively with the team to ensure the quality of our products meets regulatory requirements and industry standards.

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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