14 of 14 21 CFR Part 11 Jobs in the UK excluding London

appropriately assessed, documented, approved and validated. Interpret and apply regulatory requirements relating to Computer System Validation, Data Integrity, Electronic Records and Electronic Signatures, including 21 CFR Part 11. Support regulatory inspections, third-party inspections and internal audits while ensuring systems and documentation remain inspection-ready. The skills … Quality, Computer System Validation (CSV), or a related pharmaceutical quality role. Advanced knowledge of Computer System Validation, Software Development Lifecycle (SDLC), Global GxP regulations, 21 CFR Part 11, Electronic Records and Signatures, Data Integrity requirements, and Quality Management Systems. Practical experience reviewing the complete validation lifecycle ...

Experience working with validated systems and understanding of Computerised System Validation (CSV)/Computer Software Assurance (CSA) . Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and ALCOA+/data integrity principles . Understanding of OT cybersecurity principles and frameworks ...

with Intermediate to senior (5+ years) CSV (full lifecycle) experience. CSV experience of process equipment manufacturing API Strong knowledge of regulations (GAMP®5 and 21 CFR Part 11, Annex 11) and modern CQV CSV practices Experience of working with software/automation validation ...

data-integrity compliance. Must-Have Skills Strong hands-on CSV experience in Pharmaceutical, Biotechnology, Medical Device, or Life Sciences. Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, GxP, and Data Integrity . Experience with Computerized System Risk Assessments, audit trails, user ...

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 ...

CSRA and PQE, and installing/qualifying audit trails, IP clocks, and Wonderware/user management for Pall water. Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11 and data integrity is required. #J-18808-Ljbffr ...

including MES (Manufacturing Execution Systems), ERP, SCADA, and IoT devices. Ensure IT compliance with manufacturing industry regulations (e.g. ISO 9001, GAMP 5, ISO 27001, 21 CFR Part 11) and data integrity guidelines. Lead root cause analysis (RCA) and CAPA for IT system outages, data synchronization failures ...

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 ...

several of the following areas: Security leadership, governance, risk and compliance (GRC) Cloud security architecture and security strategy ISO 27001, GDPR, SOC 2, GxP, 21 CFR Part 11 or similar regulated frameworks Audit leadership, customer assurance and certification programs Healthcare technology, pharmaceutical, biotechnology or regulated SaaS ...

mindset, make resource trade-offs, and drive measurable commercial outcomes. Navigate the tension between speed-to-market and regulatory compliance (GxP, 21 CFR Part 11, GDPR, HIPAA). Cultivate strategic partnerships with data providers and standards bodies (CDISC, HL7 FHIR) to accelerate Evinova's product capabilities. ...

Electrical, Control or Instrumentation Engineering Advantageous Skills, Experience, or Qualifications Strong understanding of cGMP, ISO standards and regulatory expectations for computerised systems, including FDA 21 CFR Part 11 and GAMP5 Direct experience calibrating temperature and pressure instrumentsIdeal opportunity for a knowledgeable EC&I Engineer from ...

Electrical, Control or Instrumentation Engineering Advantageous Skills, Experience, or Qualifications Strong understanding of cGMP, ISO standards and regulatory expectations for computerised systems, including FDA 21 CFR Part 11 and GAMP5 Direct experience calibrating temperature and pressure instruments Ideal opportunity for a knowledgeable EC&I Engineer from ...

Ipsen, we are committed to improving the lives of patients, with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission, delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be winner of Pharma Company … underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thrive! We are seeking an experienced and driven ...

Ipsen, we are committed to improving the lives of patients, with a special focus on advancing neuroscience therapies. Our Wrexham site is a vital part of this mission, delivering cutting-edge solutions in a dynamic and collaborative environment. We are proud to be winner of Pharma Company … underway, there has never been a more exciting time to join us. If you are passionate about making an impact and want to be part of a team that values growth, innovation, and excellence, then Ipsen could be where you thrive! We are seeking an experienced and driven ...