21 of 21 21 CFR Part 11 Jobs in the UK

sciences quality and compliance.The company’s solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001.#### Who we’re looking forAs … life sciences sector.* Strong grasp of regulatory requirements and quality processes across pharma, biotech, and/or medical devices (e.g., ISO 13485, FDA 21 CFR Part 11).* Experience with eQMS implementation, preferably on Salesforce-based platforms.* Demonstrated ability to manage complex projects and lead cross ...

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 ...

Development environments. Strong working knowledge of: ISO 13485 ISO 14971 IEC 62304 Experience supporting product and software development lifecycles. Knowledge of FDA regulations, including: 21 CFR Part 820 21 CFR Part 11 FDA software validation and software development guidance Ability to manage multiple ...

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 ...

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 ...

environments. Knowledge of PLM, QMS, and Regulatory processes (change control, deviations, CAPA, audits, complaints, submissions/registrations, regulatory documentation). Working understanding of GxP, 21 CFR Part 11, EU Annex 11, data integrity and audit trails. Confident working with global stakeholders and vendors; able ...

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 ...

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 ...

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 ...

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 ...

technologies.* Strong software engineering and development experience including software development, issue management, DevSecOps, continuous integration, or cloud deployment.* Experience with software development for 21 CFR Part 11-compliant or regulated environments would be advantageous. **Soft skills:*** Proven leadership, strong communication and interpersonal skills. **Additional Details**This ...

technologies. Strong software engineering and development experience including software development, issue management, DevSecOps, continuous integration, or cloud deployment. Experience with software development for 21 CFR Part 11-compliant or regulated environments would be advantageous. Soft skills: Proven leadership, strong communication and interpersonal skills. Additional Details This ...

relevant degree or have equivalent working experience. Prior experience developing software for clinical trials such as EDC or eCOA is preferred. Prior experience with 21 CFR Part 11 regulated environment. Proven prior experience as a business analyst and delivering software products. Highly developed organization and time ...

software development for clinical trials, such as EDC (Electronic Data Capture) or eCOA (Electronic Clinical Outcome Assessment), is preferred. Understanding of regulatory environments like 21 CFR Part 11 is a plus. For more information, please contact Grant Van Schalkwyk. #J-18808-Ljbffr ...

industry experience Industry experience with preference for Rockwell Studio 5000, FT View, Ignition, Siemens TIA Portal/Step7, OSI PI Historian, VBA. Knowledge of 21 CFR Part 11 and GAMP an advantage Cisco Networking qualification and or VMware or equivalent qualification an advantage Knowledge of Robotics ...

documentation, testing and delivery. Beneficial experience Working knowledge of GxP requirements, data-integrity principles and relevant guidance, including GAMP 5, EU GMP Annex 11 and 21 CFR Part 11. Experience producing and executing validation deliverables, including risk assessments, protocols, test scripts and validation reports. Familiarity with ...

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 ...

stakeholders ensuring timelines are met and deliverables achieved. Perform CSV assessments for data integrity, electronic records/electronic signatures, using guidance from GAMP5/21 CFR categorisation requirements. Perform vendor assessments as required for projects where applicable. Assist in the development and maintenance of validation-related procedures & policies. ...