Quality Assurance Expert for Biotech Innovation

1 week ago


Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk AS Full time

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Senior QA Professional for Validation Projects

Category: Quality

Are you driven by ensuring quality standards while building new technologies for the future? Would you like to work in a dynamic, engaging, and international environment?

The position

Novo Nordisk is establishing new biotech facilities utilizing modern technology with fully automated operations and digitalized processes. You will be part of a highly experienced team, whose focus is to ensure compliance in projects redesigning existing facilities and building manufacturing plants.

As Senior Quality Assurance Professional, you will:

  • Work across the organization with expansion projects for API production
  • Be responsible for QA routines related to system design, quality risk management, supplier management, equipment qualification, and validation activities
  • Find solutions that integrate quality and compliance within the organization

You will work in expansion projects where you will be involved in all phases such as design, construction, qualification, and validation ensuring stable and robust processes.

To succeed in this role, you:

  • Hold an academic degree in Pharmacy, Engineering, or similar
  • Have several years' experience in QA/validations roles in the pharmaceutical industry
  • Have proven working experience with one or more of the following topics: Process validation, Cleaning validation, Clean Utilities, Environmental Monitoring, HVAC, Supplier Management

About the department

The PS API Expansions QA works to ensure involvement in investment projects aiming to establish compliant and timely approved facilities and setting the foundation for flawless operation of our new manufacturing plants.



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