18 of 18 21 CFR Part 11 Jobs in the UK excluding London

governance, validation, and lifecycle management of all GxP-relevant computerised systems at site. This role ensures ongoing compliance with EU GMP Annex 11, MHRA Data Integrity Guidance, GAMP5 principles, and applicable global regulatory requirements. The position provides technical oversight of electronic systems, manages validation activities, assesses system updates … implementations. Perform and document periodic system reviews to ensure ongoing validated state. Identify and close existing CSV gaps to ensure compliance with Annex 11 and data integrity requirements. EudraLex Volume 4 Good Manufacturing Practice (GMP) guidelines, laid down in Commission Directives 91/356/EEC, as amended ...

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 ...

assessments, validation planning and test execution. Maintain documentation including SOPs, validation records, configuration specifications and change records. Ensure compliance with GMP, GAMP 5, Annex 11, 21 CFR Part 11 and company quality procedures. Support internal audits, external audits and regulatory inspections. Project and Vendor Management ...

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 ...

Experience working within a pharmaceutical, biotechnology, medical device or similarly regulated environment would be highly desirable An understanding of GxP, GMP, GAMP 5, Annex 11 and 21 CFR Part 11 would be advantageous Strong understanding of IT service management and ITIL principles Excellent analytical ...

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 ...

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 ...

routing fundamentals Experience working within a GxP-regulated environment (Pharma, Biotech, Life Sciences) Hands-on experience with: GxP documentation and compliance processes Data Integrity - 21 CFR Part 11/Annex 1 System validation and lifecycle management Good understanding of SDLC within regulated environments Experience supporting ...

continuous improvement. Develop, maintain and improve manufacturing software systems, electronic records, reporting tools and digital workflows in compliance with GMP, FDA, ISO 13485, 21 CFR Part 11 and applicable regulatory requirements. Lead Computer System Validation (CSV) activities, including the development and execution of Validation Plans, Risk … both internal and external agents. Confident and effective decision maker, with a proven leadership ability to negotiate and influence others. Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment Demonstrable analytical & problem-solving skills, a process improvement orientation ...

regulated environment such as Pharma, Biotech or Life Sciences. Hands-on experience with GxP documentation, compliance and system validation. Knowledge of Data Integrity, 21 CFR Part 11 and Annex 1. Good understanding of SDLC within a regulated environment. Experience with Rockwell FactoryTalk, Mettler Toledo FormWeigh ...

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 ...

resource management skills with ability to manage multiple projects. Experience working with Quality Framework (ISO) standards (e.g.ISO27001, ISO13485) and ICH GCP, and understanding of 21 CFR Part 11 regulation. Proactive, analytical, and problemsolving skills with commitment for continuous improvement. #J-18808-Ljbffr ...

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 ...

with, in respiratory and cardiac trials where accuracy matters and the science is still developing. If you want complex datasets, are enthusiastic about being part of a growing team and clinical data that genuinely informs trial outcomes, we'd love to meet you. About the role We are looking … transfer specifications (agreements) with Sponsor, providing technical input where required. Conduct user acceptance testing on project specific configurations of the Qureight Imaging Platform. Be part of continuous improvement, suggesting and delivering revisions to work instructions and SOPs to develop best working practices in clinical data management relevant to Qureight. ...

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 ...

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 ...