Biopharmaceutical Quality Assurance Specialist

2 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time
About AGC Biologics

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.

Job Summary

We are seeking an experienced Biopharmaceutical Quality Assurance Specialist to join our team in Copenhagen. This role will be responsible for maintaining and developing our Quality Management Systems, including Deviation, CAPA, Change Control, Complaints, Training, and Document Control.

Key Responsibilities
  • Maintain and develop Quality Management Systems in compliance with current GMP regulations.
  • Collaborate with partners across all functional areas to ensure effective and efficient quality-related activities.
  • Drive improvement projects optimizing GMP Training standards and systems.
Requirements
  • An academic degree and substantial training experience in GMP-regulated environments.
  • Proven experience in planning and successfully executing projects.
  • Confidence as a trainer with strong facilitation abilities.
Benefits

As a Biopharmaceutical Quality Assurance Specialist at AGC Biologics, you can expect a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement.

The estimated annual salary for this position is around 120,000 USD, based on industry standards and the location of Copenhagen.



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