Quality Assurance Specialist, CMC
1 week ago
Quality Assurance Specialist, CMC
Lundbeck is seeking a Quality Assurance Specialist, CMC to support the progression of our pipeline of promising drug candidates by ensuring patient safety and GMP compliance of the Investigational Medicinal Product (IMP) for clinical trials.
About the Role
You will join a growing department with an exciting future ahead with expected upcoming purchase of new drug candidates. As a Quality Assurance Specialist, CMC, you will be responsible for ensuring compliance for CMC deliverables from early to late phase pipeline projects.
Key Responsibilities
- Batch record review
- QA assessment of deviations, change controls and laboratory deviations
- Approval of master batch records
- Handling complaints
- Contribute to vendor oversight (e.g vendor re-evaluations)
Requirements
- You hold a master's degree in pharmacy, chemistry, biology, or similar qualifications
- Sterile and biologic manufacturing knowledge is an advantage
- Minimum 2 years of experience in a GMP regulated environment preferably in Manufacturing, Quality Control or Quality Assurance
- Knowledge and competencies within CMC are preferred
- You are fluent in English
About Lundbeck
Lundbeck 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.
-
Quality Assurance Specialist, CMC
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeQuality Assurance Specialist, CMCLeverage your expertise in quality assurance to support the development of new treatments for brain diseases at Lundbeck. As a Quality Assurance Specialist, CMC, you will ensure patient safety and GMP compliance of Investigational Medicinal Products (IMPs) for clinical trials.Your Key ResponsibilitiesReview batch records to...
-
Quality Assurance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeQuality Assurance Specialist - CMCLundbeck is seeking a Quality Assurance Specialist - CMC to support the progression of our pipeline of promising drug candidates by ensuring patient safety and GMP compliance of the Investigational Medicinal Product (IMP) for clinical trials.About the RoleYou will join a growing department with an exciting future ahead with...
-
Quality Assurance Specialist, CMC
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe 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 ResponsibilitiesReview batch records and ensure compliance with regulatory...
-
Quality Assurance Specialist, CMC
4 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our CMC Development QA team. As a key member of our team, you will be responsible for ensuring patient safety and GMP compliance of Investigational Medicinal Products (IMPs) for clinical trials.Key ResponsibilitiesBatch record review and QA assessment of deviations, change...
-
Quality Assurance Specialist, CMC Development
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeQuality Assurance Specialist, CMC DevelopmentLundbeck is seeking a Quality Assurance Specialist to support the development of new treatments for brain diseases. As a key member of the CMC Development QA team, you will ensure patient safety and GMP compliance of Investigational Medicinal Products (IMPs) for clinical trials.Your Key ResponsibilitiesReview...
-
Quality Assurance Specialist, CMC
4 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our CMC Development QA 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 ResponsibilitiesReview batch records and ensure compliance with GMP...
-
Quality Assurance Specialist, CMC
7 days ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeQA Academic, CMC Job DescriptionWe are seeking a highly skilled QA Academic, CMC to join our team at Lundbeck. As a QA Academic, CMC, you will play a critical role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.Your Key ResponsibilitiesReview batch records to ensure compliance with GMP...
-
Quality Assurance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeUnlock Your Potential in CMC DevelopmentLundbeck is seeking a highly skilled Quality Assurance Specialist to join our CMC Development team. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.About the RoleYou will be responsible for reviewing...
-
Quality Assurance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeUnlock Your Potential in Pharmaceutical Quality AssuranceLundbeck is seeking a highly skilled and motivated Quality Assurance Specialist to join our CMC Development QA team. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our investigational medicinal products (IMPs) for clinical trials.About the RoleYou...
-
Quality Assurance Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeQuality Assurance SpecialistLundbeck is seeking a Quality Assurance Specialist to support the development of new treatments for brain diseases. As a key member of the CMC Development QA team, you will ensure patient safety and GMP compliance of Investigational Medicinal Products (IMPs) for clinical trials.Your Key ResponsibilitiesReview batch records and...
-
Quality Assurance Specialist
3 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeUnlock Your Potential in Pharmaceutical Quality AssuranceLundbeck is seeking a highly skilled Quality Assurance Specialist to join our CMC Development QA team. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.About the RoleYou will be...
-
Quality Assurance Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeUnlock Your Potential in Pharmaceutical Quality AssuranceLundbeck is seeking a highly skilled Quality Assurance Specialist to join our CMC Development QA team. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.About the RoleYou will be...
-
Quality Assurance Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeUnlock Your Potential in Quality AssuranceLundbeck is seeking a highly skilled Quality Assurance Specialist to join our CMC Development QA team. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.About the RoleYou will be responsible for...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeGMP/GDP Auditor, CMC Development and Quality Assurance Specialist This is an exciting opportunity for an international position as a GMP/GDP auditor in CMC Development and Quality Assurance, supporting the development of new innovative treatments for brain diseases. In this role, you will have a vital part as a lead auditor conducting external audits of...
-
Quality Assurance Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our CMC Development QA team at Lundbeck. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.Key ResponsibilitiesReview batch records and ensure compliance with...
-
GMP/GDP Auditor
3 days ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeGMP/GDP Auditor - CMC Development Quality Assurance At Lundbeck, we are seeking a skilled GMP/GDP Auditor to join our CMC Development QA team. As a key member of our team, you will be responsible for conducting external audits of CMC vendors and internal audits of CMC, ensuring compliance with regulatory requirements. Your role will involve...
-
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleWe are seeking a highly skilled Senior QP Delegate to join our CMC Development QA team at Lundbeck. As a Senior QP Delegate, you will play a critical role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) for clinical trials.Key ResponsibilitiesQP confirmation of Biologic Bulk Drug Substance and Drug...
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timeJob Title: Quality Assurance Specialist for Development GMP ActivitiesAscendis Pharma A/S is seeking a highly skilled Quality Assurance Specialist to join our Development QA - Chemistry team in Copenhagen. As a key member of our QA team, you will play a vital role in ensuring the quality oversight of our outsourced development activities.Key...
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma AS Full timeQuality Assurance Specialist for Development GMP ActivitiesAscendis Pharma A/S is seeking a highly skilled Quality Assurance Specialist to join our Development QA team in Copenhagen. As a key member of our team, you will be responsible for ensuring the quality oversight of outsourced development activities carried out at our Contract Laboratories and...
-
Copenhagen, Copenhagen, Denmark Ascendis Pharma Full timeJoin Our Team as a QA Specialist for Development GMP ActivitiesAre you passionate about Quality Assurance and have expertise in outsourced GMP activities and development projects? Ascendis Pharma is seeking a dedicated QA Specialist to join our highly skilled QA team in Copenhagen.We're a dynamic biopharmaceutical company with a strong focus on innovation...