Validation Specialist for Pharmaceutical Quality Systems
1 week ago
We 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 of our pharmaceutical quality systems. In this role, you will be responsible for developing and executing test plans and protocols, ensuring compliance with industry standards and regulatory requirements, collaborating with cross-functional teams to troubleshoot and resolve software and hardware issues, conducting risk assessments, and maintaining documentation for quality assurance processes.
You will also contribute to the improvement of QA processes to enhance software reliability and performance, and participate in projects within core competencies.
This is an excellent opportunity to work in a dynamic environment, where you will have the chance to grow and develop your skills in Agile methodologies, demonstrate adaptability and a collaborative mindset, and make a significant impact on our company's success.
Your Key Responsibilities- Develop and execute test plans and protocols for laboratory equipment software
- Ensure compliance with industry standards and regulatory requirements
- Collaborate with cross-functional teams to troubleshoot and resolve software and hardware issues
- Conduct risk assessments and maintain documentation for quality assurance processes
- Improve QA processes to enhance software reliability and performance
-
QA Specialist for Validation
3 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJobbeskrivelsePlacering Bagsværd, DenmarkJobkategori Quality Ansøg nu Would you like to play an important role in ensuring the quality and safety of products for clinical trials, where you can use your solid QA and validation experience in a project context? Then we can offer you a unique position with a lot of responsibility and impact in a dynamic and...
-
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...
-
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...
-
Validation Specialist for CMC API Quality
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the TeamClinical Trials Operations is a department that employs over 40 skilled and motivated colleagues. We work together to assure quality and compliance of the CMC API facilities & equipment and release of raw materials, cell banks, and API for clinical trials. Our team values teamwork, diversity, and humour, and we strive to create an inclusive...
-
Quality Assurance Specialist
2 weeks 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 Management System Strategist
7 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the DepartmentThe Quality Management System Strategist will be part of the RDQ Operational Excellence department within R&D Quality Operations, committed to the continuous improvement and simplification of the Quality Management System (QMS). Our team consists of 10 highly skilled individuals with different roles and responsibilities, specializing in...
-
Senior Quality Assurance Specialist
3 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the RoleWe are seeking a skilled Senior Quality Assurance Specialist to join our team at Novo Nordisk A/S. As a key member of our quality assurance unit, you will play a vital role in ensuring patient safety by delivering high-quality standards for our products and production processes.Key ResponsibilitiesEvaluate and approve documents related to...
-
Quality Assurance Specialist
2 weeks 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...
-
Technical ERP Implementation Specialist
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Fusion Consulting GmbH Full timeFusion Consulting GmbH, a leading Life Sciences boutique consultancy, is seeking a highly skilled Technical ERP Implementation Specialist to join our team.Job OverviewThe successful candidate will be responsible for the implementation of an ERP solution for Local/Regional Manufacturing and Affiliate with go live in May 2025.This role involves working closely...
-
ERP Systems Integration Manager
1 week ago
Gladsaxe, Gladsaxe Municipality, Denmark Fusion Consulting GmbH Full timeFusion Consulting GmbH is a global leader in business and IT consulting, serving the Life Sciences industry. We strive to deliver exceptional solutions that drive business excellence.Job SummaryThe ideal candidate will have a strong background in ERP implementation, configuration management, and technical design documentation. They will work closely with an...
-
Quality Control Method Validator
2 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob SummaryThe QC Chemistry department at AGC Biologics is seeking a highly skilled Chromatography Expert to join their team. This role requires expertise in troubleshooting chromatographic methods, especially (U)HPLC, iCIEF, and CGE-SDS.Key ResponsibilitiesTroubleshoot chromatographic methodsDrive PhI/II and PhIII/Commercial method validation...
-
Senior Quality Systems Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeOverviewThe Clinical Quality Management System (QMS) department at Novo Nordisk A/S plays a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes and procedures. As a Principal GCP Advisor, you will be part of this team and contribute to driving digital quality excellence. About the RoleIn this...
-
Pharmaceutical QA Professional
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeAbout the DepartmentDigital Health & Staffs Quality consists of a group of engaged and motivated QA specialists and Project Managers. We are QA for global Digital Health, QA for Customer service, Novo Nordisk Staff areas and a CVP area called Complaints, Audits & Inspections. We have the QA oversight for these processes and contribute to projects from a QA...
-
Quality Systems Engineer
4 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeWe are looking for a skilled Quality Systems Engineer to join our Plant Engineering team. As a Quality Systems Engineer, you will be responsible for ensuring compliance with regulatory requirements and company standards. Your primary duties will include developing, implementing, and maintaining quality systems, procedures, and policies.You will collaborate...
-
Quality Control Specialist
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark FERROSAN MEDICAL DEVICES AS Full timeDo you want to be a part of our Quality Control team in a successful company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own...
-
Quality Assurance Specialist in MSAT
1 week 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...
-
Packaging Innovator for Pharmaceutical Products
2 weeks ago
Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full timeJob Overview We're seeking an experienced Primary Packaging Engineer to join our team at Novo Nordisk A/S. In this role, you'll play a key part in the development and implementation of primary packaging solutions for injectable pharmaceuticals. You'll work closely with cross-functional teams to ensure the delivery of high-quality products that meet customer...
-
Quality Assurance Specialist
2 weeks 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,...
-
Life Science IT Transformation Consultant
6 days ago
Gladsaxe, Gladsaxe Municipality, Denmark Fusion Consulting GmbH Full timeWe are seeking a highly skilled Technical ERP Implementation Specialist to join our team at Fusion Consulting GmbH.The successful candidate will be responsible for the implementation of an ERP solution for Local/Regional Manufacturing and Affiliate with go live in May 2025.This role involves working closely with an international team and the supplier to...