Quality Assurance Principal Scientist

1 month ago

Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk AS Full time
Job Title: Quality Assurance Principal Scientist

Job Summary:

We are seeking a highly experienced Quality Assurance Principal Scientist to join our team at Novo Nordisk A/S. As a key member of our API QA Operational and Business Support department, you will be responsible for ensuring the right and balanced compliance level in API (QC) laboratories. Your expertise will be invaluable in setting scientific direction within QA for QC & MDEV and developing the organization and team scientifically.

Key Responsibilities:
  • Serving as a QA specialist and partner for API QC and MDEV.
  • Taking responsibility and participating as QA for API in the Novo Nordisk Focus Groups related to QC and MDEV.
  • Acting as a sparring partner for stakeholders when it comes to QA for new groundbreaking technologies, providing technical expertise and guidance on quality-related issues.
  • Handling analytical transfer of methods as well as qualification of apparatus and validation of methods and setting the standards.
Qualifications:
  • Master's degree in natural sciences or a related field, and +5 years of experience in Quality Control and manufacturing in the pharmaceutical industry.
  • Solid experience in API (Active Pharmaceutical Ingredient) manufacturing and development.
  • Strong knowledge of QC methods, processes, and regulations.
  • In-depth knowledge about automation flow in QC.
  • Competencies within PAT (Process Analytical Technology) techniques.
About the Department:

In our department API QA Operational and Business Support, we are 42 highly dedicated employees, mostly specialized academics, divided into 2 teams. The API QA Operational Support team is the QA function for QC and MDEV, furthermore, they are QA for API business support functions (example: metrology, technical warehouse) and we are QA for a corporate function in Novo Nordisk Quality, Quality systems.

Working at Novo Nordisk:

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 are anchored on scientific innovation through the power of our diverse differences. We embrace the spirit of experimentation and strive for excellence without fixating on perfection.

We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we are all working together to advance patient care.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures.

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