Quality Assurance Specialist, CMC

2 weeks ago


Copenhagen, Copenhagen, Denmark Lundbeck Full time

About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our CMC Development team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.

Key Responsibilities

  • Review batch records and ensure compliance with regulatory requirements
  • Conduct QA assessments of deviations, change controls, and laboratory deviations
  • Approve master batch records and ensure their accuracy
  • Handle complaints and ensure timely resolution
  • Contribute to vendor oversight and re-evaluations

Requirements

  • Master's degree in pharmacy, chemistry, biology, or a related field
  • Minimum 2 years of experience in a GMP regulated environment, preferably in manufacturing, quality control, or quality assurance
  • Knowledge of CMC regulations and guidelines is an advantage
  • Fluency in English is required

What We Offer

Lundbeck offers a dynamic and collaborative work environment, with opportunities for professional growth and development. We are committed to building a diverse and inclusive team, and we welcome applications from candidates with a wide range of backgrounds and experiences.

How to Apply

If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity. Please upload your CV and a brief statement outlining your motivation for applying.



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