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Quality Assurance Specialist

1 week ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

At AGC Biologics, we are driven by a shared purpose to bring hope to life through innovative therapies.

We are seeking an experienced Quality Assurance Specialist to join our dynamic team in Copenhagen. As the ideal candidate, you will possess a strong background in quality management and a deep understanding of Good Manufacturing Practice (GMP) principles.

The role is critical in ensuring that our production facilities and laboratories comply with current GMP standards, including EU GMP, 21 CFR, and ICH guidelines at all times.

Your key responsibilities will include:

  • Overseeing Quality Assurance reviews and approvals of technical documents, such as change controls, deviations, CAPAs, risk assessments, SOPs, validation plans, requirements specifications, qualification protocols, and reports.
  • Conducting regular GEMBA walks in GMP areas to ensure adherence to quality standards.
  • Communicating effectively with internal and external stakeholders to resolve issues and clarify points of concern.
  • Contributing to the development of standard operating procedures (SOPs) for qualification, calibration, maintenance, cleaning, and other facility and engineering activities.

To succeed in this role, you must have a self-motivated personality with a practical approach to daily tasks, while maintaining a commitment to quality.

You should possess:

  • A science-based degree.
  • Experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site.
  • Prior biopharmaceutical experience is desirable.
  • A thorough understanding of GMP principles and guidelines.
  • Experience with the qualification of GMP facilities, equipment, and computerized systems.
  • Knowledge of Data Integrity principles.
  • Strong decision-making skills and a proactive attitude.
  • Excellent written and verbal communication skills.
  • Ability to work efficiently in a fast-paced, matrix environment.
  • Ability to meet deadlines and effectively manage multiple tasks.
  • Flexibility to adapt to changing business needs and priorities.