3 of 3 21 CFR Part 11 Jobs in the UK excluding London

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 ...

Coordinate with external vendors regarding system upgrades, patches, and service-level agreements. Implement and maintain validated states for computerized systems in compliance with GxP, 21 CFR Part 11, and EU Annex 11. Develop, execute, and maintain validation protocols for IT systems and laboratory informatics platforms. Support ...

communication skills; willing and able to travel internationally (5% of the time). Desirable: Experience in pharmaceutical automation, GAMP5/21CFR11/EU Annex 11 compliance. Knowledge of electrical, mechanical, and pneumatic principles. Exposure to machine vision, robotics, SCADA/MES, .NET, and SQL. Why 3P Innovation? Join ...