IT/OT QA Specialist

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 pos...