1 of 1 21 CFR Part 11 Jobs in the East Midlands

division. You will work closely with the Validation Manager to ensure systems (including SAP) and quality processes meet GDP, ISO, FDA, and EU Annex 11 standards. Your Tasks Lead and support Computer System Validation (CSV) activities, including planning, executing, and documenting validation, re-validation, and change controls for systems … electronic QMS, and temperature monitoring systems. Strong documentation, analytical, and organisational skills. Knowledge of GAMP 5, validation principles, GDP, ISO 9001/13485, FDA 21 CFR Part 11, and EU Annex 11. Experience in healthcare, pharmaceutical, or medical device environments. Confident in audits, inspections, and presenting ...