Computer system validation engineer / specialist
CorkAdvanced Manufacturing Tech Solutions
...support approval of CSV documentation (Validation Plans, URS, Risk Assessments, IQ/OQ/PQ, Reports) Support risk-based validation approaches for new and existing systems Ensure CSV activities comply with cGMP, GAMP 5, Annex 11, and 21 CFR Part 11 Support project teams to align validation activities with project timelines [...]
Category Engineering & Architecture