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Copenhagen, Copenhagen, Denmark Lundbeck Full timeThis is a unique opportunity to contribute to the development of innovative treatments for brain diseases. As our new Senior QP Delegate, you will be responsible for ensuring GMP compliance of Investigational Medicinal Product (IMP) supplies for Lundbeck ́s clinical trials.You will join a growing department with an exciting future ahead, supporting our...
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeOverviewLundbeck is a global leader in the development of innovative treatments for brain diseases. Our clinical trials require Investigational Medicinal Product (IMP) supplies that must adhere to Good Manufacturing Practice (GMP) standards.About the RoleWe are seeking a Senior QP Delegate to join our CMC Development QA team, supporting the progression of...
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior Vendor Specialist, CMC Development QA ProfessionalWe are seeking an experienced Senior Vendor Specialist to join our CMC Development QA team. As a Senior Vendor Specialist, you will be responsible for ensuring the quality and compliance of our vendors, driving the continuous development of our vendor management program, and leading audits and vendor...
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeSenior QP Delegate Role Overview:This is a unique opportunity to contribute to the development of new treatments for brain diseases, supporting GMP compliant Investigational Medicinal Product (IMP) supplies for Lundbeck's clinical trials. As a Senior QP Delegate, you will be part of our newly established team, leveraging your professional and personal...
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeRole OverviewWe are seeking a skilled Senior Vendor Specialist to join our CMC Development team as a QA lead for the vendor management program. This is a great opportunity to contribute to the development of new innovative treatments for brain diseases while driving the continuous improvement of our vendor management program.About the JobAs a Senior Vendor...
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeAt Lundbeck, we are seeking an experienced QA Specialist to lead our vendor management program in CMC Development. As a key member of our team, you will play a crucial role in ensuring compliant vendor oversight of our Contract Manufacturing Organizations (CMOs) for clinical trials.We offer an exciting opportunity to work with a broad range of tasks,...
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Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout LundbeckLundbeck is a global pharmaceutical company with a rich history of developing innovative treatments for brain diseases. Our mission is to bring life-changing therapies to patients in need.Job OverviewWe are seeking a highly skilled Senior Vendor Specialist to join our CMC Development QA team. This is an exciting opportunity to work on the...
Senior QP Delegate, CMC Development QA Specialist
1 month 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. As a Senior QP Delegate, you will join our newly established QP delegate team, leveraging your professional and personal competencies. We offer an exciting job with a great opportunity to impact our processes and a broad variety in your daily work while ensuring compliance for CMC deliverables from early to late phase pipeline projects.
Your 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 collaborate with multiple stakeholders in CMC, regulatory affairs, commercial QA etc. You will contribute to our continued development of the Quality Management System by authoring and approving SOP ́s governing the activities.
What We OfferLundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.
