Computerized Systems Validation (CSV) Expert

Operating system, WindowsYour responsibilities, Define, plan, and report CSV activities in alignment with regulatory expectations (e.g. FDA 21 CFR Part 11, Annex 11)., Review and approve validation documentation (e.g. URS, risk assessments)., Support of the CSV activities in the main CSV areas: Production Systems, Enterprise Systems Laboratory Systems., Support CSV activities by monitoring progress and escalating risks to ensure smooth business operations., Collaborate with users, subject matte…