Compliance QA Specialist for IT Systems

2 weeks ago


Køge, Køge Kommune, Denmark Novo Nordisk AS Full time

About the Role


We are currently seeking a Compliance QA Professional for IT solutions to help us set the direction for Quality Management of digital and IT solutions and services in a regulated environment at Novo Nordisk Pharmatech A/S in Køge.



Key Responsibilities



  • Acting as a QA partner regarding GMP compliance towards the IT department
  • Approval of deviations, change requests, qualification, and validation documentation


About the Team


The QA/RA department currently consists of 20 employees working diligently to support the entire value chain, from Research & Development to Production and finally Sales & Marketing. We cover quality and regulatory affairs related communication with the authorities, our B2B customers, our distributors, and our suppliers.



Requirements



  • An Academic degree within Engineering, Science, Pharmacy, Chemistry, Biotechnology, IT/automation or similar
  • Experience within Quality Assurance, Quality Control, Production Support or similar
  • Experience with GMP (Good Manufacturing Practice)
  • Flair for, and interest in, IT; experience with software validation would be an advantage (GAMP5)
  • Professional proficiency in English; knowledge of Danish will be considered an advantage


About Us


Novo Nordisk Pharmatech A/S is a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries, supplying products such as recombinant insulin for cell growth media and pharmaceutical grade quaternary ammonium compounds as well as raw materials for Novo Nordisk A/S.



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