Senior Quality Assurance Specialist in CMC API QA
1 month ago
We are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. The successful candidate will serve as QP delegate, primarily responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline.
Key Responsibilities- Ensuring best-in-class quality assurance of our API for clinical trials in phase I, II, and III testing.
- Challenge and approve documents related to the development, manufacture, stability, and status assignment of internal and external produced API.
- Ensuring that our products used in clinical trials are following the information provided to Health Authorities worldwide.
- Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements.
CMC API QA is a department that employs 35 skilled and motivated colleagues in four teams, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials, as well as the release of API for all clinical trials within Novo Nordisk.
Qualifications- A Master in Pharmacy, Engineering, Biology, Chemistry, or similar to fulfill the requirements to become a "Qualified Person" (QP), according to The Danish Medicines Agency certification.
- Extensive experience in a pharmaceutical company, ideally also in a QA role.
- A profound understanding of the important aspects of regulations, requirements, and guidelines for pharmaceutical development and production.
- Proficiency in English and Danish.
- Proficiency in SAP and/or PasX along with experience with API and CMOs, will be seen as an advantage.
At Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection.
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionJob SummaryWe are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. The successful candidate will serve as QP delegate, primarily responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline.Key Responsibilities• Ensure...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team as a QP delegate, primarily responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline.Key Responsibilities:Ensuring best-in-class quality assurance of our API for clinical...
-
API Quality Assurance Specialist
1 day ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeWe are seeking a highly motivated and experienced Quality Assurance Professional to join our Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA team at Novo Nordisk A/S.The successful candidate will support CMC API Development within the raw material and Contract Manufacturer (CMO) shipping area. This role is responsible...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the Job:We are seeking a highly skilled Quality Assurance and Validation Specialist to join our team at Novo Nordisk A/S.Key Responsibilities:Set the quality direction for the capacity expansion projectDeliver best-in-class quality for qualification of equipment/facilities and IT-systemsHandle larger and complex quality issuesEnsure a LEAN culture and...
-
Advanced Quality Assurance Specialist
4 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S. The successful candidate will support CMC API Development within the raw material and CMO shipping area.Key ResponsibilitiesEnsure compliance with regulatory requirements, quality standards, and company...
-
Quality Assurance Specialist for Validation
1 month ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our CMC API QA team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our CMC API facilities and equipment.Key ResponsibilitiesDevelop and implement quality strategies to ensure compliance with regulatory requirementsConduct...
-
Advanced Quality Assurance Expert
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly motivated Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S. The successful candidate will support CMC API Development within the raw material and CMO shipping area.Key ResponsibilitiesDeliver best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeQuality Assurance Specialist RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk A/S in Bagsværd, Denmark.About the RoleThis is an exciting opportunity to work in a dynamic and professional environment where you will play a crucial role in ensuring the quality and safety of products for clinical trials.You will...
-
Principle Quality Assurance Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob SummaryAGC Biologics is seeking an experienced QA Scientist to join our team in Copenhagen. The successful candidate will be responsible for supporting Supply Chain, Process Transfer, and QC for late-stage and commercial products.Key ResponsibilitiesClose collaboration with internal stakeholdersChange control, deviation handling, and CAPAsReview and...
-
Senior Quality Assurance Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance (QA) Scientist to join our team at AGC Biologics. As a QA Scientist, you will play a crucial role in ensuring the quality of our products and processes, adhering to Good Manufacturing Practice (GMP) standards.Key ResponsibilitiesOversee the quality assurance review and...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled IT Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a key member of our Quality Control team, you will be responsible for ensuring the highest level of quality and compliance in our laboratory equipment.Key ResponsibilitiesDevelop and execute test plans and protocols for laboratory equipment...
-
Customer Service Quality Assurance Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleThe Digital Health & Staffs Quality department at Novo Nordisk A/S is seeking a highly skilled Customer Service QA Professional to join their team. As a key member of the department, you will be responsible for ensuring the quality and compliance of Customer Service processes across the organization.Main ResponsibilitiesAs a Customer Service QA...
-
Customer Service Quality Assurance Specialist
1 month ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled and experienced Quality Assurance Professional to join our team at Novo Nordisk. As a Customer Service Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our customer service processes.Key ResponsibilitiesProvide quality assurance input on designing and...
-
Senior Quality Assurance Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionJob Title: QA SpecialistJob Category: QualityLocation: Bagsværd, DenmarkAbout the JobWe are seeking a skilled QA specialist to join our team in securing the quality and safety of Novo Nordisk's products.As a QA specialist, your main task will be to ensure patient safety by delivering high-quality standards for our products and production...
-
Key Player in CMC API Development
2 days ago
Gladsaxe, Gladsaxe Municipality, Denmark IT Minds Full timeWe are currently seeking a highly skilled and proactive Personal Assistant to the Corporate Vice President (CVP) of Chemistry, Manufacturing and Control (CMC) Development & Scaling in our IT Minds organisation. This role is an excellent opportunity for individuals who thrive in fast-paced environments and are eager to contribute to the success of our...
-
Customer Service Quality Assurance Expert
2 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Customer Service Quality Assurance Expert to join our team at Novo Nordisk A/S in Søborg, Denmark.Job OverviewThis is a unique opportunity to shape the future of Customer Service in Novo Nordisk for the benefit of our patients across the world. As a Customer Service Quality Assurance Expert, you will work with...
-
Quality Assurance Specialist
6 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAre you a motivated and experienced Quality Assurance professional looking for a new challenge? Do you have a strong background in quality management and a passion for ensuring compliance with regulatory requirements?We are seeking a highly skilled Quality Assurance Specialist to join our team at AGC Biologics. As a Quality Assurance Specialist, you will be...
-
Senior PI System Engineer
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking an experienced PI System Engineer to join our CMC API Pilots team at Novo Nordisk. As a PI System Engineer, you will be responsible for the development, implementation, and operation of our Data Historian Platform, which plays a critical role in making data available for reporting, batch release, and manufacturing...
-
Scientist, Quality Assurance Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeQuality Assurance Specialist Opportunity at AGC BiologicsWe are seeking a highly skilled Quality Assurance Specialist to join our Quality Systems team in Copenhagen, Denmark.Key Responsibilities:Collaborate with partners to optimize GMP Training standards and systems.Develop new training standards, courses, and programs to support business needs and...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Expert to join our team at Novo Nordisk A/S. As a QA Specialist, you will play a crucial role in ensuring patient safety and delivering high-quality standards for our products and production processes.This is an exciting opportunity to work in a fast-paced environment with a strong focus on...