Quality Assurance Specialist for Manufacturing Operations

2 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

At AGC Biologics, we strive to bring hope to life by enabling life-changing therapies for patients worldwide.

Our QA Manufacturing Support Scientist plays a vital role in ensuring the quality and integrity of our manufacturing processes.

The key responsibilities of this position include:

  • Providing real-time quality support to manufacturing operations, ensuring compliance with GMP requirements and procedures.
  • Reviewing manufacturing records and logbooks to identify and address any quality-related issues.
  • Collaborating with manufacturing teams to resolve issues and implement process improvements.
  • Participating in Gemba walks and conducting site systems audits to ensure adherence to quality standards.
  • Reviewing and approving validation and qualification documentation to ensure compliance with GMP regulations.
  • Liaising with production management to resolve any quality-related queries or issues.

For this role, we are seeking an individual with:

  • A Bachelor's or Master's degree in Natural Sciences or a related field.
  • Experience working in a GMP environment, preferably in the biopharmaceutical industry.
  • Strong knowledge of GMP principles and guidelines.
  • Excellent written and verbal communication skills.
  • Ability to work in a fast-paced matrix environment and prioritize multiple tasks.

This role is located at our Copenhagen Site.



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