Senior QP Delegate Expert, CMC Development Quality Assurance
3 days ago
This role offers an exciting opportunity to contribute to the development of innovative treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck's clinical trials.
You will join a newly established QP delegate team, leveraging your professional and personal competencies, to drive the continuous improvement of quality processes.
The department is responsible for efficient and compliant quality processes to support the development of Small Molecule and Biologic drug candidates, including device activities.
You will be working primarily in DK time zone from our office in Valby with occasional online meetings.
We offer a unique position for you to build upon your experiences and professional development, with great opportunities to grow your competencies and knowledge and to widen your duties and responsibility as you develop in the role.
Key Responsibilities:
- QP confirmation of Biologic Bulk Drug Substance and Drug Product
- QP certification of IMP
- QA assessment of deviations, change controls and laboratory deviations
- Approval of master batch records
- Handling of complaints
Requirements:
- You hold a master's degree in pharmacy or similar qualifications to meet the requirements of a QP Delegate
- Experience in biologic drug substance manufacturing
- At least 5-10 years of experience in a GMP regulated area either in Manufacturing, Quality Control or Quality Assurance
- Previous experience as a QP delegate would be an asset
- You are fluent in English
About Lundbeck:
Lundbeck is a global leader in the development and manufacturing of innovative treatments for brain diseases, with a strong commitment to quality and compliance.
We offer a collaborative and dynamic work environment, with opportunities for professional growth and development.
If you are a motivated and experienced professional looking to join a leading pharmaceutical company, we encourage you to apply for this exciting opportunity.
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeJob Title: Senior QP Delegate, CMC Development QAThis is a unique opportunity to contribute to the development of innovative treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck ́s clinical trials.Your Role - Why is this a Great Opportunity?You will join a growing department with an exciting...
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