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

Summary Solution Leadership and Architecture Lead technical solutioning for MES opportunities as part of the Solution Engineering team. Responsibilities Solution leadership and architecture lead technical solutioning for MES opportunities as part of the Solution Engineering team. Architect design, build, deploy and maintain MES Lite solutions using leading vendor … PLCs, historians, LIMS and cloud platforms. Define scalable application frameworks, reusable components and governance standards. Compliance and Quality: Ensure solutions meet 21 CFR Part 11, Annex 11 and Data Integrity requirements. Partner with Quality and Validation teams to streamline compliant delivery. Business and Practice Development ...

System Administrator (GxP Systems) 3-Month Contract | part time | Surrey | Inside IR35 We're looking for a System Administrator with experience supporting validated systems in regulated environments (GxP/GMP) . Key Responsibilities: System administration, maintenance, and patch management Testing and validation activities (CSV/GxP) System implementation … Change Control & Patch Management Compliance & Audit Readiness System Lifecycle Management CAPA & Risk Management Vendor & Stakeholder Management Project Delivery & Coordination Desirable: GMP, GxP, FDA 21 CFR Part 11, Annex 11 Working Pattern: 2-3 days per week Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio ...

control tools such as Git would be beneficial. Experience working within pharmaceutical, medical device or regulated manufacturing environments would be advantageous. Knowledge of GAMP, 21 CFR Part 11, EU Annex 11 or GMP would be beneficial. Strong communication skills with the ability to work effectively … exciting opportunity to join a growing automation business where you will work on innovative machinery projects within highly regulated industries. You will be part of a collaborative engineering environment that values learning, innovation and continuous improvement. 3P Innovation promotes a culture built around: Innovation challenging assumptions, exploring new ideas ...

connect process development to manufacturing, enabling faster, more reliable tech transfer and batch release. Ensure architecture patterns comply with Life Sciences regulatory frameworks: GxP, 21 CFR Part 11, EU Annex 11, GAMP 5and data integrity requirements. Collaborate with client quality and regulatory affairs teams ...

Programming Git version control Basic electrical, mechanical and pneumatic knowledge Robotics Machine Vision SCADA/MES systems Pharmaceutical or regulated manufacturing environments GAMP, GMP, 21 CFR Part 11 or EU Annex 11 Industrial communication protocols including EtherCAT, Profinet, CAN, Ethernet/IP and Serial communications … .NET and SQL Why Join 3P Innovation? At 3P Innovation, you'll become part of a business built around innovation, collaboration and integrity. You'll work on technically challenging, one-off automation projects where no two days are the same, alongside experienced engineers who genuinely enjoy solving complex manufacturing ...

technical stakeholders. A practical, commercially aware and solutions‐focused approach. Experience with LIMS, ELN platforms, laboratory systems, GxP, MHRA guidance or FDA 21 CFR Part 11 would be particularly valuable. What’s next? If you are an experienced IT leader who enjoys combining strategy with hands ...

diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel … hosting, security, etc.) in enabling on-premise and cloud IT solutions. Knowledge of data integrity and compliance standards within a GxP-regulated environment (e.g., 21 CFR Part 11). Solution architecture certifications for Microsoft Azure or Google Cloud Platform. Experience working in a product operating model ...

investigate and track defects through to resolution Collaborate with engineering, product, applications and quality teams Support release qualification and (where applicable) regulated documentation incl. 21 CFR Part 11 What we're looking for Proven software testing/QA experience (strong manual testing background) Systems-thinking mindset ...

authoring policies and procedures (SOPs). Experience conducting audits and gap assessments. Experience managing internal personnel, contract resources, and projects. Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents. Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents ...

authoring policies and procedures (SOPs). Experience conducting audits and gap assessments. Experience managing internal personnel, contract resources, and projects. Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents. Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents ...

within the medical device industry. Strong knowledge of medical device design, development and Quality Management Systems (QMS). Working knowledge of ISO 13485, FDA 21 CFR Parts 820 & 11, and EU MDR (2017/745). Experience leading internal, external and regulatory audits. Understanding of risk management ...