QA Specialist

About the Company

Magle Biopolymers is part of the Magle Group – an international life science group with strong roots in dextran technology. We develop and manufacture advanced polymer-based materials used in medical products, contributing to improving patients’ lives.

Responsibilities

• Support production with QA responsibilities
• Perform batch record review and support batch release activities
• Handle deviations, CAPA, change controls and other day to day quality issues
• Participate in root cause investigations and help define effective corrective and preventive actions
• Ensure that documentation is clear, correct and completed according to internal procedures
• Identify opportunities to improve quality processes and routines within production
• Contribute to LEAN initiatives and other improvement activities
• Work together with production, QC, supply chain and other departments
• Provide guidance on quality requirements and support internal audits

Requirements

• 3+ years of QA experience from GMP or ISO 13485 environments
• Degree in Life Science, Engineering, Pharmacy or similar
• Strong understanding of quality principles and documentation practices
• Proficiency in Danish and English (spoken and written)
• Ability to work independently with operational quality tasks

Preferred Qualifications

• Experience in a pragmatic and solution-oriented QA role
• Ability to prioritize tasks effectively in a production environment