Senior QP Delegate, CMC Development QA Specialist
3 weeks ago
This 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.
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
You will join a new team headed by the Qualified Person, collaborating with multiple stakeholders in CMC, regulatory affairs, commercial QA, and other departments.
Requirements- 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
- Fluency in English
Lundbeck is a global pharmaceutical company committed to developing innovative treatments for brain diseases. We offer a collaborative and inspiring work environment, passionate colleagues, and a culture characterized as collaborative.
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior QP Delegate, CMC Development QA SpecialistThis 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. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your...
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior 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. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your professional...
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior QP Delegate, CMC Development QAThis is a great opportunity to contribute to the development of new innovative treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck ́s clinical trials. You will leverage your professional and personal competencies to drive the continuous improvement of the...
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior QP Delegate, CMC Development QA RoleThis is 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. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your...
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior 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. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your professional...
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