IT/OT QA Specialist
Q
Quanta part of QCS Staffing
📍 Copenhagen, Copenhagen, Denmark
Job Description
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...
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: