4 21 CFR Part 11 Jobs in the UK

develop technology solutions deployed in clinical trials - such as CTMS or other relevant technologies Familiarity with navigating the clinical trial lifecycle and adhering to 21-CFR Part 11 regulations and validation processes Well-versed in the utilisation of common tools and technologies within clinical trials, including … Keywords: clinical, data, management, manager, quality, systems, process, compliance, controls, tools, CSV, validation, regulatory, compliance, computer, systems, SDTM, ADAM, CDISC, SAS, Snowflake, QA, audit, 21-CFR Part 11, Director, VP, drug, development, R&D, discovery, IT, pharmaceutical, biotech, operations more »

ability to analyse and chart data in Excel is essential. Experience with Computerized Systems Validation and knowledge of ISPE's GAMP and FDA 21CFR Part 11 would be advantageous. Adherence to SOPs and experience with a QMS will be required. The ideal candidate will have a life-science more »

Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products. • Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred. • Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred. more »

English (ideally with business French). Nice to Haves Data Protection Officer certification. Knowledge of regulatory requirements specific to the pharmaceutical industry (e.g., FDA 21 CFR Part 11). Experience with Agile or Scrum Methodologies. Proficiency in Electronic Document Management Systems (EDMS) and other quality management more »