Biopharmaceutical Quality Assurance Specialist

4 weeks ago


Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

About the Role

We are seeking a skilled Biopharmaceutical Quality Assurance Specialist to join our team at AGC Biologics in Copenhagen. As a vital member of our multidisciplinary team, you will play a crucial role in ensuring the quality and compliance of our production facilities and laboratories.

Job Summary

The successful candidate will be responsible for overseeing the Quality Assurance review and approval of all technical documents, conducting GEMBA walks in GMP areas, communicating with internal and external stakeholders, and contributing to setting standards for Qualification, Calibration, EM, cleaning, and other facility and engineering activities.

Key Responsibilities

  • Review and approve technical documents, including Change Controls, Deviations, CAPAs, Risk Assessments, SOPs, Validation Plans, Requirements Specifications, Qualification Protocols, and Reports.
  • Conduct regular GEMBA walks in GMP areas to ensure compliance and identify areas for improvement.
  • Communicate effectively with internal and external stakeholders to resolve issues and clarify points of concern.
  • Collaborate with the team to establish and maintain high-quality standards for Qualification, Calibration, EM, cleaning, and other facility and engineering activities.

About You

To succeed in this role, you will need to possess a science-based degree, experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site, prior biopharmaceutical experience, and a thorough understanding of Good Manufacturing Practice (GMP) principles and guidelines.

Requirements

  • A science-based degree.
  • Experience working in or directly supporting manufacturing operations in a drug substance/product manufacturing site.
  • Prior biopharmaceutical experience is desirable.
  • Thorough understanding of Good Manufacturing Practice (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.

Working at AGC Biologics

We offer a dynamic and supportive working environment, where you will have the opportunity to work with a talented team of professionals who share your passion for delivering high-quality products and services.

What We Offer

  • A competitive salary of approximately DKK 550,000 - 650,000 per year (dependent on experience).
  • A comprehensive benefits package, including health insurance, pension scheme, and paid holidays.
  • Opportunities for professional development and growth within the company.
  • A dynamic and supportive working environment.

How to Apply

If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your application and resume for consideration.



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