8 of 8 21 CFR Part 11 Jobs in England

Quality team supporting the implementation of our next generation patient-centric remote clinical trial solutions. What will you do? You will be an integral part of our Quality team responsible for ensuring that the development and configuration of our software products is maintained in accordance with GxP rules, regulations … development of computerised systems throughout the product lifecycle. Ensuring that the Validation Strategy supports relevant GxP, Data Protection and Privacy Requirements (e.g. EU Annex 11, FDA 21 CFR Part 11, 21 CFR Part 820, GDPR, HIPAA etc.) Reviewing and approving changes to … thorough working knowledge of Atlassian JIRA and/or Veeva QualityOne Good personal organisation and problem-solving skills A proven ability to work as part of a multi-disciplinary team in a commercial environment Strong people skills and the ability to influence others Candidates with past commercial experience in More ❯

s your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey to make healthcare more efficient through Technology. Salary: Up to £65,000 + Bens Location: Fully Remote (UK) The Role We … API-based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and More ❯

s your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey to make healthcare more efficient through Technology. Salary: Up to £65,000 + Bens Location: Fully Remote (UK) The Role We … API-based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and More ❯

MSc or PhD (or equivalent) in Mathematics, Statistics, Computer Science or related subject preferred Solid understanding of the pharmaceutical regulatory and publishing processes (e.g., 21 CFR Part 11) Advanced expertise in end-to-end clinical trial process and application of key clinical documents Expertise in Oncology More ❯

people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. The Systems Engineer, level 3 will support ongoing Lonza operations through technical assistance as it relates to computerized systems infrastructure for process automation … with support and guidance from supervisor. Own change requests and participate in all aspects of the change control system. Learn, understand and comply with 21 CFR Part 11 regulations. Assist the Quality department with deviation investigations. Participate in RCAs as Operations Information Systems (OIS) representative. Review More ❯

systems, SCADA systems, and PC networking technology. Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products. Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11. More ❯

evaluated in terms of Data Integrity impact to achieve compliance in systems, applications, and processes implementations. Ensure that Data Integrity principles and processes are part of the Audits/Inspections Program for Convatec Sites to ensure compliance with current regulations. Risk Management (RM): Support continuous improvement and matureness of … within FDA (GxP) regulated environments. Knowledge/experience in CSA (Computer Software Assurance) and related processes/documentation. Knowledge and experience in GxP Guidelines; 21 CFR - Parts: 11, 210, 211, 820-QSR; Annex 11- ERES. Experience validating and qualifying applications for different business areas as HR More ❯

process). Maintaining detailed records and documentation of validation activities. Validating lab instrument software, managing change control, and configuration activities, with knowledge of 21CFR part 11 requirements. ABOUT YOU: The ideal candidate will hold a bachelor's degree in a scientific discipline and have prior experience in analytical More ❯