4 of 4 21 CFR Part 11 Jobs in the 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 ...

Working closely with the Validation Manager, you will ensure that systems-including SAP-meet the highest standards of GDP, ISO, FDA, and EU annexe 11 compliance. Your Tasks Will Include: Leading and supporting Computer System Validation (CSV) activities, including planning, executing, and documenting validation and change controls. Preparing … 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 annexe 11. Experience in healthcare, pharmaceutical, or medical device environments. Confidence in audits, inspections, and presenting ...

Working closely with the Validation Manager, you will ensure that systems-including SAP-meet the highest standards of GDP, ISO, FDA, and EU annexe 11 compliance. Your Tasks Will Include: Leading and supporting Computer System Validation (CSV) activities, including planning, executing, and documenting validation and change controls. Preparing … 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 annexe 11. Experience in healthcare, pharmaceutical, or medical device environments. Confidence in audits, inspections, and presenting ...

Working closely with the Validation Manager, you will ensure that systems-including SAP-meet the highest standards of GDP, ISO, FDA, and EU annexe 11 compliance. Your Tasks Will Include: Leading and supporting Computer System Validation (CSV) activities, including planning, executing, and documenting validation and change controls. Preparing … 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 annexe 11. Experience in healthcare, pharmaceutical, or medical device environments. Confidence in audits, inspections, and presenting ...