Risk Manager for Primary Packaging Solutions
2 weeks ago
About the Role
As a Risk Manager for Primary Packaging, you will play a crucial part in the Life Cycle Management (LCM) of Risk Management documentation packages related to Primary Packaging (PrimPack).
Working in close collaboration with R&D, Production, and Supply Chain, you will be responsible for reviewing and updating Risk Evaluation and Control Agreements when implementing new or modified Drug Products or combination products.
You will also oversee the process for transfer of the risk package to PrimPack Injectables and govern the process for LCM of PrimPack product risk documents, ensuring they are ready for periodical reviews.
Key Responsibilities
- Review and update Risk Evaluation and Control Agreements for new or modified Drug Products or combination products
- Oversee the process for transferring the risk package to PrimPack Injectables
- Govern the process for LCM of PrimPack product risk documents
- Ensure processes are compliant with internal and external requirements
Requirements
- Master's degree or Ph.D. in engineering or a relevant field within the natural sciences
- Experience working in a GMP environment with risk management tools and methodologies
- Strong understanding of medical device regulations and standards
- Proven track record of successfully managing risk within medical device development projects
About the Department
You will join the Material Manufacturing Development - Primary Packaging Department in Product Supply, Sourcing Operations, working at the company headquarters in Bagsværd, Copenhagen.
The department consists of approximately 50 employees, organized in 4 teams, and is responsible for implementing complex Primary Packaging materials and maintaining documentation on existing materials.
We cooperate with various functions, including CMC, Device R&D, QC laboratories, QA, and external suppliers and contract manufacturers (CMO).
Working at Novo Nordisk
We are a proud life-science company, inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges.
For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work.
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