6 21 CFR Part 11 Jobs

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 »

the validation and validation maintenance of computerised systems associated with Processes, Facilities, Equipment, Manufacturing Execution Systems (MES), and IT systems Ensure compliance with GAMP, 21 CFR Part 11, Annex 11, and data integrity requirements Qualifications: BSc in a Science, Engineering or Computer Science related discipline more »

depth knowledge of DeltaV automation platform , including configuration, programming, and troubleshooting capabilities. Familiarity with regulatory requirements and standards governing automated process manufacturing, such as 21 CFR Part 11, GAMP 5, and IEC 62304. Strong analytical and problem-solving skills, with the ability to assess complex technical … negative, we will contact you to halt the recruitment process. Working at PQE Group As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation . PQE Group gives you the opportunity to work on international projects , improve your 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 »

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 »

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 »