21 of 21 21 CFR Part 11 Jobs in England

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 ...

platform’s next chapter - a Patient Registry solution, electronic data capture platform, and a validated ePRO library. Ship a regulatory‐grade product, considering e.g. 21 CFR Part 11 audit trails and eConsent with e‐signatures. Treat compliance as a design constraint to engineer around … ePRO/eCOA, eConsent, patient registry, or sensor‐based study platforms. Hands‐on experience shipping under GCP/ICH E6(R3), 21 CFR Part 11, and EU Annex 11, including computer system validation and audit‐ready release management. Working fluency in clinical data standards, especially ...

organisation needs. You will work as a direct partner to our engineering teams and alongside our dedicated Regulatory Affairs leadership. Regulatory is not part of this role, but a function you will collaborate closely with. At CoMind, all team members work at least 4 days per week from … Leadership: Lead and develop our existing Quality team, instilling and maintaining a high performance culture. Ensure the CoMind QMS complies with the FDA QMSR (21 CFR Part 820, harmonised with ISO 13485) and 21 CFR Part 11 for electronic records and signatures, while ...

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 ...

driven platform to help advance the treatment of neurological disorders and reduce the uncertainties associated with drug discovery, development and monitoring. As a key part of the global neurological disease research community, the Company has built a global reputation and 20-year track record … software development and validation policies and procedures, ensuring best practice for ‘security & privacy by design’ principles and in compliance with current GCP, FDA 21 CFR Part 11, EU Annex 11, GAMP, FDA QSR Part 820 (QMSR), EU MDR (Regulation 2017/ ...

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 ...

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 ...

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 ...

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 ...

About NTT DATA Business Solutions: NTT DATA Business Solutions Group is part of the NTT DATA Corporate Group a top 10 global IT services provider, headquartered in Tokyo, operating in more than 50 countries. We combine a global reach with local intimacy to provide premier professional SAP services from … approach in fast-paced delivery environments. Particularly valuable experience The following experience would be highly beneficial: Pharmaceutical, life sciences or healthcare programme delivery. GxP, 21 CFR Part 11 and regulated validation environments. Computer System Validation (CSV), equipment validation and IQ/OQ/PQ approaches. Performance ...

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 ...

Benchling preferable) or comparable laboratory informatics platform, including schemas, modules and custom workflows. Understanding of regulatory standards including GxP, ALCOA+ principles, and 21 CFR Part 11 requirements. Desirable: Knowledge and understanding of the cell and gene therapy industry. Experience designing and implementing system integrations using APIs ...

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. ...

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. ...