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Quality System IT Specialist

Ingeniør i København

Quality System IT Specialist

We are looking for an experienced Quality System IT Specialist to join our Global Quality Systems and Training team (GQST). Your role will be as a global business process owner for some of our key quality processes. The position will be based in Copenhagen; however, some travel should be expected.

What will you do?
As our new Quality System Specialist, you will be a global business process owner for some of our processes, including but not limited to data integrity, computer system validation, Good Automated Manufacturing Practices (GAMP), and risk management.
In this role, you will be expected to:

  • deliver process improvement activities, update procedures, and oversee the implementation
  • design, create, and plan delivery of training across multiple sites
  • identify, define, and implement appropriate key performance indicators
  • collect the data needed to measure and manage process performance
  • establish and/or lead a process or sub-process core team with guidance
  • understand how relevant IT systems support/enable the business process
  • Partner with our global IT function and advise on GxP compliance

You will become part of an experienced team
The Global Quality Systems, Audits and Compliance (GQSAC) department consists of 16 highly specialized individuals divided into four t...

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