Senior Quality Assurance Specialist

2 days ago

Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk Full time

About the Role

We are seeking a highly experienced and skilled Senior Quality Assurance Specialist to join our team at Novo Nordisk. As a key member of our API QA Operational and Business Support department, you will play a critical role in ensuring the quality and compliance of our products.

Key Responsibilities

  • Serve as a QA specialist and partner for API QC and MDEV, providing technical expertise and guidance on quality-related issues.
  • Take responsibility for participating as QA for API in the Novo Nordisk Focus Groups and related to QC and MDEV.
  • Act as a sparring partner for stakeholders when it comes to QA for new groundbreaking technologies, providing technical expertise and guidance on quality-related issues.
  • Handle analytical transfer of methods as well as qualification of apparatus and validation of methods and setting the standards.
  • Be a main actor in fulfilling the QC strategies and being QA responsible in future strategic initiatives in the laboratories.
  • Continuously participate in other cross-functional activities to support the development and optimization of manufacturing processes and the implementation of new technologies and analytical methods to improve product quality and efficiency.

Requirements

  • Master's degree in natural sciences or a related field, and 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.
  • Process development experience within integrated methods, which involves the development and optimization of integrated manufacturing processes that incorporate multiple unit operations and analytical techniques to improve efficiency and product quality.
  • Experience in managing working groups and teaching at all levels.
  • Excellent communication and collaboration skills, and fluency in English.

About the Department

Our department API QA Operational and Business Support is a team of 42 highly dedicated employees, mostly specialized academics, divided into 2 teams. We focus on maintaining a social work environment where there is a high level of engagement, focus on development while also having fun. We love professional challenges, and we take pride in delivering on our commitments.

About Novo Nordisk

We are 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.

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