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IT/OT QA Specialist

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. Data Centres
34378

This vacancy has now expired

IT/OT QA Specialist - Life Sciences - Copenhagen - 12-Month Contract 

Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a IT/OT QA Specialist to join them on their new expansion project. Based in a charming Nordic location, this on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.


Responsibilities and Requirements:
  • Provide review of current SOPs according to regulations and support in updating and completing IT/OT QMS project.
  • Ensuring that project schedules conform to the Change Control Process, in terms of liaison, communication and calculation of change notes and change order (15%).
  • Solid experience within IT/OT pharma regulatory (e.g. Annex 11, Part 11 and Gamp guides)
  • Good experience with writing SOPs.
  • Experience with coordination in global matrix organization (project management).
  • If possible: CDMO best practice knowledge, NIS2,

If this role is of interest to you, please apply now! 

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