3 of 3 Remote 21 CFR Part 11 Jobs in England

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 ...