Research and Development Quality Assurance Specialist
7 days ago
About the Position
As a key member of the QC Stability Team, you will be responsible for handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. You will work closely with stakeholders such as customers, project managers, management, your own department, and QA to identify and manage analytical stability packages needed for projects.
Your primary responsibilities include:
- Writing and reviewing CAPA documents, deviations, and change controls
- Developing and reviewing customer-specific stability protocols and reports
- Collaborating with customers on stability-related topics
- Overseeing testing at external laboratories
- Evaluating compliance with relevant cGMP guidelines (EU, FDA)
About the Department
You will join the QC Support team in the QC laboratory, where you will collaborate with highly dedicated scientists and technicians. The QC Support department consists of three teams: QC Raw materials, QC Samples & Service, and QC Stability.
About the Ideal Candidate
We are seeking an MSc holder in Biochemistry, Pharmaceutical Sciences, or a related field with relevant experience in quality control or quality assurance. In addition to this, we expect the ideal candidate to possess some of the following skills and qualifications:
- Strong knowledge of DS/DP stability and cGMP principles
- Experience in managing change controls, deviations, and CAPAs
- Knowledge of chromatographic and bioassay methods
- Excellent communication skills in English, both spoken and written
- Demonstrated ability to drive continuous improvement and productivity programs
- A team player with the ability to work independently
The ideal candidate thrives in a dynamic environment and enjoys a rapid pace of work. They bring a positive attitude and a good sense of humor.
-
Quality Assurance Specialist
1 week ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout Us:At AGC Biologics, we strive to bring hope to life by enabling life-changing therapies for patients worldwide.We are a leading global Contract Development and Manufacturing Organization dedicated to improving life quality through the development and manufacturing of protein-based therapeutics and cell and gene therapies.Our Mission:To work side by...
-
Quality Assurance Specialist in MSAT
3 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeWe are looking for a skilled and experienced Quality Assurance Specialist in MSAT to join our team. As a critical member of our MSAT department, you will be responsible for ensuring the quality of new raw materials and single-use systems introduced into our facility.Your expertise in quality assurance, regulatory compliance, and GMP raw material management...
-
Quality Assurance Specialist
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the JobWe are seeking a highly skilled and experienced Quality Assurance Specialist to join our team at Novo Nordisk A/S. The successful candidate will be responsible for ensuring that our quality management system is in compliance with regulatory requirements, and will play a key role in maintaining high-quality products.The position covers QA...
-
Quality Assurance Specialist
1 week ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Integrated Quality department, you will be responsible for overseeing quality processes and optimizing business operations across various areas within Novo Nordisk.Your primary focus will be on ensuring adherence to regulatory standards,...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled IT QA Professional to join our team as a Senior Quality Assurance Specialist for Laboratory Equipment. As a key member of our QA team, you will be responsible for ensuring the high quality of our laboratory equipment software.In this role, you will develop and execute test plans and protocols, ensure compliance...
-
Senior Quality Assurance Specialist
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout UsNovo Nordisk A/S is a global healthcare company with a vision to drive change to defeat chronic disease. Our company is built on the passion of our people, and we are committed to creating innovative solutions that make a real difference in the lives of patients.We are seeking a highly motivated and experienced Quality Assurance Professional to join...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team in ensuring the quality and safety of products for clinical trials. As a Validation Specialist for CMC API Quality, you will play a key role in optimizing our production capacity for phase 3 clinical trials.In this dynamic environment, you will work closely with our QA...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAs a key member of our team, you will be responsible for ensuring the highest quality standards in our contract manufacturing organizations (CMOs). This role requires a high level of knowledge in quality assurance and management systems (QMS), as well as experience working with pharmaceutical manufacturing processes. You will work closely with our QA team to...
-
Digital Health Quality Assurance Specialist
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleThe Digital Health & Staff Quality department at Novo Nordisk A/S is seeking a highly skilled and motivated Quality Assurance (QA) Professional to join their team. As a QA Professional, you will be responsible for providing quality oversight and support to various processes within the Complaints, Audits & Inspections area.ResponsibilitiesEnsure...
-
Scientific Quality Assurance Specialist
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob DescriptionThis is a one-year temporary position in the QC Stability Team within the Quality Control department at AGC Biologics. The team handles stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. As a key member of the team, you will collaborate with stakeholders to ensure smooth project execution.The successful...
-
Quality Assurance Professional
13 hours ago
Gladsaxe, Gladsaxe Municipality, Denmark PARETO SECURITIES AS Full timeWe are seeking a highly skilled Quality Assurance Professional to facilitate the implementation of a sustainable quality strategy in our business. As a key member of our team, you will be responsible for promoting a quality mindset and conducting quality-related training to relevant stakeholders across the organization.Key Responsibilities:You will...
-
Solar Quality Assurance Expert
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark European Energy AS Full timeJob OverviewEuropean Energy A/S is seeking a Solar Quality Assurance Expert to join our EPC Sourcing & Procurement team. As a key member of our team, you will be responsible for ensuring the quality and reliability of our solar projects.About the RoleThe successful candidate will be responsible for handling quality control activities, including inspections,...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout Our TeamWe are a vibrant and positive working environment, consisting of 67 highly knowledgeable and skilled people, covering the diverse area of AMSAT. Our team works closely with our five laboratories responsible for stability and release samples in Denmark.We are seeking a Validation Specialist to join our team, responsible for ensuring the quality...
-
Senior Quality Assurance Professional
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob OverviewWe are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team at Novo Nordisk A/S.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.This role requires a deep...
-
Quality Assurance Manager
3 days ago
Gladsaxe, Gladsaxe Municipality, Denmark PARETO SECURITIES AS Full timeAre you passionate about ensuring the highest quality in renewable energy projects?We are seeking an experienced Quality Specialist to join our team at European Energy. As a Quality Specialist, you will play a key role in implementing and maintaining our quality management systems (QMS) across the organization.About the RoleYou will contribute to the...
-
Raw Materials Quality Assurance Expert
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAbout the RoleWe are seeking a skilled professional to join our QC Raw Materials team as a quality assurance expert. This individual will be responsible for ensuring the highest standards of quality in raw material samples and play a critical role in maintaining our reputation for excellence.Main ResponsibilitiesSampling and testing raw materials to meet...
-
Quality Assurance Manager
3 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeR&D Compliance ExpertiseThe Quality & Compliance Partner will play a key role in ensuring compliance with GxP and GDPR regulations in the R&D Data Governance Office. This involves monitoring, assessing, and advising on applicable external requirements, as well as contributing to the development and improvement of Standard Operation Procedures, guidance...
-
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAs a key member of our Quality Assurance team at AGC Biologics, you will play a critical role in ensuring the quality and integrity of our products. Our team is dedicated to upholding the highest standards of quality and customer satisfaction, and we are seeking a skilled QA scientist to join us in this mission.In this role, you will support Supply Chain...
-
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeAt AGC Biologics, we are committed to bringing hope to life by enabling life-changing therapies for patients around the globe. We strive to create a healthier and happier tomorrow by working side by side with our customers to improve patients' lives through new biopharmaceuticals.We are seeking an experienced QA scientist to join our diverse team of highly...
-
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeKey ResponsibilitiesEnsure 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 externally produced API.Participate in regulatory inspections and audits and ensure compliance with cGMP and other...