4 of 4 21 CFR Part 11 Jobs in the UK

Experience: Strong knowledge of GxP Good Documentation Practices. Understanding of the Validation V Model (GAMP5). Knowledge of FDA regulatory requirements for information systems (21 CFR Part 11 and Part 820). Experience with ERP systems or foundational ERP knowledge. Clear understanding and experience … Microsoft Word, Excel, PowerPoint, Outlook, Teams, and AI tools such as Copilot. Ability to work independently, manage own workload effectively, and collaborate as part of a team. CSV Coordinator Due to the volume of applications received for positions, it will not be possible to respond to all applications ...

Infrastructure and Networks. An understanding of IT Qualification activities would be beneficial. An understanding of Electronic Records and Electronic Signatures, e.g. USA 21 CFR Part 11, EU GMP Guidelines, Chapter 4, Annex 11 and GAMP 5. An understanding and appreciation of a Quality Management role ...

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 ...