Senior Quality Assurance Specialist

1 month ago


Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk Full time
About the Role

We are seeking a highly skilled Senior QA Professional to join our team at Novo Nordisk. As a key member of our GCM QA Drug Substance area, you will be responsible for ensuring the quality of our outsourced production activities worldwide.

Key Responsibilities
  • Lead the quality responsibility for technical transfers to Contract Manufacturing Organizations (CMOs) and ensure compliance with GMP requirements.
  • Negotiate and implement quality agreements, approve process validation strategies, and set up QA processes for commercial manufacturing.
  • Manage quality issues during technical transfers, including process validation documentation, deviations, and out-of-specifications.
  • Participate in qualification audits and ensure follow-up on CAPAs.
Requirements
  • Academic degree in Pharmacy, Engineering, or a related field.
  • Several years of experience in the pharmaceutical industry, preferably in QA or production.
  • Knowledge of quality, validation, and GMP requirements.
  • Fluency in English.
About the Department

The GCM QA Drug Substance area is a dynamic team of 35 professionals, divided into 4 teams and departments, with a focus on operations or projects. We prioritize good social relations and make room for fun at work.

About Novo Nordisk

We are a proud life-science company, inspired by life in all its forms and shapes. Our mission is to ensure that people can lead a life independent of chronic disease.



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