26 to 30 of 30 21 CFR Part 11 Jobs in the UK

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 ...

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. ...