17 of 17 21 CFR Part 11 Jobs in the UK

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 ❯

trust environment with the client's counterparts. Main Job Tasks and Responsibilities: Implement software systems in conformance with regulatory requirements as they pertain to CFR 21 Part 11. Ensure compliance with corporate initiatives and company standards. Develop and maintain a comprehensive IT Quality Assurance Program in support … transactions and run tests to find errors and confirm programs meet specifications. Consult with suppliers to prototype, refine, test, and debug programs to attain CFR 21 Part 11 compliance/approval. Write and maintain documentation to describe program development, logic, coding, testing, changes, and corrections. Provide …/or unclear. Effective verbal and written communication skills. Ability to clearly document and report testing-effort results. Ability to work independently or as part of a team in the resolution of problems and completion. Knowledge of IT QA procedures and processes including acceptance testing procedures, defect tracking, benchmarking More ❯

field. Experience in pharmaceutical, biotech, or healthcare technology sectors. Prior involvement in achieving compliance in both SOC 2 and GxP contexts. Familiarity with FDA 21 CFR Part 11, EU Annex 11, or similar regulations. What We Offer A key role in a high-impact compliance More ❯

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 for Dot … Competitive salary and benefits package. Generous PTO/Vacation plan. Paid holidays. 401(k) plan with company match. Remote work environment. Opportunity to be part of a dynamic and growing team. Responsibilities: Maintain consistent digital interactions with customers, providing support and assistance as needed. Manage and negotiate renewal & expansion 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 ❯

a highly embeddable, framework-agnostic component for seamless integration. Balance Innovation with Compliance : Build a modern interface that meets strict regulatory demands (HIPAA, GDPR, 21 CFR Part 11). Enhance Research Impact : Support life sciences professionals reviewing pathology slides in cutting-edge clinical trials. Control Your 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 ❯

endpoint products and IRT system. Leads and coordinates the preparation and modification of quality system procedures compliant with respective regulatory standards, such as 21CFR part 11, EU Annex 11 and other applicable standards and regulations. Collaborates closely with Operations, R&D, IT and other Compliance areas to 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 ❯

team Requirements: 8+ years experience of life sciences automation with growing levels of responsibility In depth knowledge and illustrated experience of working with GAMP, 21 CFR Part11 etc. Excellent ability for working with people and leading teams Energy, passion and vision to drive growth strategy Technical background in More ❯

team Requirements: 8+ years experience of life sciences automation with growing levels of responsibility In depth knowledge and illustrated experience of working with GAMP, 21 CFR Part11 etc. Excellent ability for working with people and leading teams Energy, passion and vision to drive growth strategy Technical background in More ❯

specifications, technical reports, risk assessments). Experience with additional PLC/HMI/SCADA manufacturers. Awareness of regulatory expectations around computerised systems (GAMP5, FDA 21 CFR11, EU ANNEX 11. Company: Our client is improving people's lives and health outcomes by focusing on areas of high unmet medical need. More ❯

documents (specifications, technical reports, risk assessments) Experience with additional PLC/HMI/SCADA manufacturers Awareness of regulatory expectations around computerised systems (GAMP5, FDA 21 CFR11, EU ANNEX 11 Company: Our client is improving people's lives and health outcomes by focusing on areas of high unmet medical More ❯