LSC has a fantastic opportunity for an IT/OT QA Specialist to join an advanced global team in Denmark that promotes self-development, encourages collaboration, and fosters a learning environment. The company specialises in clinical & commercial manufacturing of Biotech medicines, including viral gene therapies and has built a strong reputation over the years for bringing complex and lifechanging therapies into reality. This is a chance for you to be a part of a fast-growing, multicultural company that has a compelling vision for shaping the future of medicine.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- 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%).
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Solid experience within IT/OT pharma regulatory (e.g. Annex 11, Part 11 and Gamp guides)
- Good at writing SOPs
- Experience with coordination in global matrix organization (project management)
- If possible: CDMO best practice knowledge, NIS2,
Apply via this advert or contact Paul O'Driscoll at +353 214771329 if you have any more questions about this opportunity!
