Quality Assurance Specialist

3 weeks ago


Søborg, Gladsaxe Municipality, Denmark Novo Nordisk Full time

About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Novo Nordisk. As a QA Project Lead, you will be responsible for ensuring the quality and compliance of our contract manufacturing operations worldwide.

Main Responsibilities

  • Quality responsibility for the technical transfer to the CMOs in market and capacity expansion projects
  • Taking lead in ensuring the CMO Quality Management System (QMS) is compliant to fulfil relevant GMP requirements
  • Ensuring good collaboration with the CMO and building the Quality mind-set and Compliance culture at the CMO
  • Negotiation and implementation of quality agreements, approving process validation strategy and related documents
  • Setting up the QA processes for commercial manufacturing
  • Participating in qualification audits performed at the CMO and ensuring sufficient follow up on CAPAs

Requirements

  • Hold an academic degree as Pharmacist, Engineer or similar
  • Have a minimum of 5 years' experience from the pharmaceutical industry either from production or QA
  • Have a solid and up-to-date knowledge of quality and GMP requirements and the ability to take decisions on quality representing Novo Nordisk
  • Be proficient in English and knowledge of other languages will be an advantage

About the Department

Global Contract Manufacturing (GCM) QA is responsible for quality assurance and quality support to outsourced production activities worldwide. In LMCO QA one of the primary roles is to deliver QA support and set direction for CMO's in countries where local presence is required to maintain market access.

Working at 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 embrace the spirit of experimentation, striving for excellence without fixating on perfection.



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