6 21 CFR Part 11 Jobs

the design, development, testing, and optimisation of embedded software solutions for company’s existing and future products. The candidate will co-operate closely as part of an innovative and passionate cross-functional engineering team to deliver high-quality firmware that meets performance, reliability, and scalability criteria. Embedded Software Engineer … skills. Desirable knowledge, skills and experience Industrial communications experience such as Profibus, Profinet, Ethernet IP and PLC integration Electronics circuit design Awareness of FDA 21 CFR Part 11 compliance requirements Experience working to ISO13485 standards Benefits Package: Relocation assistance, profit share paid twice a year 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 »

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 »

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 »

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 »

Assurance, Computer Systems Validation & Computer Software Assurance. A sound knowledge of IT Security, GDPR & IT Systems & Infrastructure. Experienced with Q-Systems (eg EU: Annex 11/FDA: 21CFR Part 11). Ideally experienced in the Medical Technology Sector. A knowledge of important IT Standards & Methods (eg ISO27001 more »