Scientist, QA Manufacturing Support
3 days ago
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
The QA Manufacturing Support Scientist is responsible for quality activities supporting Manufacturing Operations in accordance with procedures and GMP requirements. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real-time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.
Primary Role (daily responsibilities):
- Provide an “on-line” Quality presence in the production area during manufacture regarding on the line documents and product checks and quality support for production enquiries. To inform line management of any issues relating to the quality of products or materials.
- Perform QA sign off after set-up to confirm that the manufacturing line has been set up as per requirements in batch documentation and associated SOPs.
- Conduct batch record “Stage Approval” as part of batch release process.
- Participate in Gemba walks of the production area and conduct specific site systems audits in accordance with the agreed schedule.
- Shipping/ prepacking approval.
- Manufacturing label management.
- Archiving.
- Review and approval of validation/ qualification documentation.
- Review all batch documentation, liaising with production management to resolve and clarify any points of issue.
- Work with manufacturing to drive improvements in GMP compliance across all shifts.
- Support manufacturing during batch review with Good Documentation Practice related queries.
- Perform Quality review and approval of deviations (DEVs), change controls (CRs) and CAPAs.
- Buffer and media MPR review and approval.
Education and Experience:
- Bachelor's and/or Master’s degree in Natural Sciences.
- Alternatively, certified laboratory technician with a degree in laboratory science, biotechnology, medical laboratory technology including 3-5 years experience within a GMP environment in the Pharma Industry.
- Experience with BPR/MPR review will be a plus.
- Previous biopharma experience is preferred but not a requirement.
- Strong working knowledge of the principles and guidelines for GMP is a plus.
- Strong decision maker and ‘can do’ attitude.
- Excellent written and verbal communication skills to internal and external stakeholders.
- Ability to work in a fast-paced, matrix environment is essential.
- Capable of working to deadlines and prioritizing multiple tasks.
- Flexibility to meet changing needs and priorities of the business.
- Experience working in a GMP aseptic manufacturing environment will be a plus.
Location: Copenhagen Site
#J-18808-Ljbffr-
Scientist, Manufacturing
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Do you have experience working in a cGMP environment and are you looking...
-
Scientist Manufacturing Product Support
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeAs a CDMO, AGC Biologics manufactures drugs for a variety of different customers. Depending on the customer needs, this can be drugs ranging from development, to clinical and commercial production. Right now, you have the opportunity to join the Manufacturing Product Support department as we have several open positions across the department within upstream,...
-
QC Bioassay Senior Scientist
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Are you looking for an exciting job in a fast-growing international CDMO...
-
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. AGC Biologics is looking for an experienced QA scientist to assist with...
-
Senior Scientist, Quality Assurance
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. Would you like to be a part of AGC Biologics' growing success? We are...
-
Senior Manager for QA Support
3 days ago
Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full timeAre you a skilled leader with a strategic mindset, and a passion for driving cross-functional activities? Are you ready to take on a dynamic role where you can make a real impact across organizational borders? We are seeking a Manager to join our Finished Product Manufacturing (FPM) QA Management team and head up FPM QA Support at Novo Nordisk. Apply today...
-
Advanced QA for External Production at CMO
3 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Advanced QA for External Production at CMO Category: Quality Location: Søborg, Capital Region of Denmark, DK Do you want to work in one of the most interesting and challenging areas in Novo Nordisk? Are you passionate about Quality Assurance and Quality Management Systems (QMS)? Are you eager to...
-
12 months Temporary Scientist
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeOur purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. AGC is looking for a Scientist / Sen. Scientist with expertise and...
-
Senior QP delegate in CMC API QA
3 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials and thereby secure and support the development pipeline in Novo...
-
QA Manager
1 week ago
Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Are you a highly motivated leader, driven by complex challenges with experience in QA? Do you want to be part of a fantastic QA team that values team spirit, empowerment, and good collaboration with our stakeholders? Are you passionate about motivating and supervising a team and helping them...
-
Senior QA Professional
3 days ago
Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full timeDo you want to be part of expanding our CMO business, to have international business impact and are you ready to make a difference for millions of patients? Are you passionate about Quality Assurance and Quality Management Systems (QMS)? Do you want to work in one of the most interesting and challenging areas in Novo Nordisk and eager to take your...
-
Temporary Scientist, Quality Control
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeThis is a one year temporary QC Scientist position. You will be a part of the QC Stability Team which is a part of Quality Control handling stability studies of Drug Substance, Drug Product, Placebo and Reference Material. Your working day is characterized by ongoing collaborations with stakeholders such as customers, project managers, management, your own...
-
Scientist, Quality Control
3 days ago
Gladsaxe Kommune, Denmark AGC Biologics Full timeThe Position You will be a part of the QC Stability Team which is a part of Quality Control handling stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. Your working day is characterized by ongoing collaborations with stakeholders such as customers, project managers, management, your own department, and QA. Along with your...
-
Advanced QA Professional
3 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so, this position as QA Professional in Chemistry,...
-
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeJob OverviewWe are seeking an experienced Senior Quality Assurance Specialist to support our biologics manufacturing operations.Key ResponsibilitiesCollaborate closely with internal stakeholders to ensure effective quality management.Support Supply Chain, Process Transfer, and QC for late stage and commercial products.Review and approve material...
-
QA Specialist for Validation
3 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Bagsværd, Denmark Jobkategori 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...
-
QA Specialist
3 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Bagsværd, Denmark Jobkategori Quality Ansøg nu We are looking for a skilled QA specialist, to take part in a strong, evolving, and fast-moving organisation with a significant role in securing the quality and safety of Novo Nordisk's products. Does this sound like a job for you? Then you may be the person we are looking for to...
-
Customer Service QA Professional
3 days ago
Gladsaxe Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Søborg, Denmark Jobkategori Quality Ansøg nu Are you passionate about quality, business understanding and communication with many stakeholders across the company? Do you want to shape the future of Customer Service in Novo Nordisk for the benefit of our patients across the world? If so, this is a unique opportunity to become QA...
-
Manufacturing Process Specialist
5 days ago
Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full timeOur purpose at AGC Biologics is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow.Do you have experience working in a cGMP environment and are you looking for new opportunities for further growth?As a Contract Development and Manufacturing Organization (CDMO), we manufacture...
-
QA Professional
3 days ago
Gentofte Kommune, Denmark Novo Nordisk AS Full timeJobbeskrivelse Placering Gentofte, Denmark Jobkategori Quality Ansøg nu Are you passionate about ensuring high-quality products that transform lives? Thrive in a fast-paced environment with ample collaboration opportunities? Join our AMSAT QA for QC team! Apply today for a life-changing career. The position As QA, your key task is to ensure products...