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GMP Quality Assurance Professional
3 weeks ago
Lundbeck A/S, H is a global leader in the discovery and development of innovative treatments for brain disorders. We are committed to transforming lives by addressing the big unmet needs of people living with brain disorders.
We are seeking a GMP Quality Assurance Professional - Biologics Manufacturing to join our team in Copenhagen, Denmark. As a member of our CMC Development QA organization, you will play a critical role in ensuring the quality and compliance of our small molecule and biologic drug candidates.
Key Responsibilities:
- Batch record review for biologics and small molecules
- QA assessment of deviations, change controls, and laboratory deviations
- Approval of master batch records
You will work closely with multiple stakeholders in CMC and contribute to the continued development of our processes. Our CMC Development QA organization consists of approximately 20 employees based in Copenhagen and Seattle, US who work together to ensure efficient and compliant quality processes.
About the Role:
- You hold a master's degree in pharmacy, chemistry, biology, or a similar qualification
- Preferably 1-2 years of experience in a GMP regulated environment in manufacturing, quality control, or quality assurance
- Sterile and biologic manufacturing knowledge is an advantage
- Knowledge and experience within CMC are preferred
- You are fluent in English
Your Career Path:
Lundbeck offers rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.
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