3 of 3 21 CFR Part 11 Jobs in London

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 ❯

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 ❯