Software Quality
il y a 2 semaines
TheSoftwareQuality & Risk Engineer permanent positionis based in Meylan, (nearby Grenoble).YOUR ROLE:As part of Kayentis Quality & Regulatory team, you contribute to the quality and reliability of Kayentis Solutions by ensuring development activities are carried out in accordance with regulatory requirements applicable to computerized systems used in clinical investigations.Participate in the maintenance, continuous improvement, and training of processes related to the design and development of Kayentis Solutions and Services, including the appropriate consideration of :-Risk management-Validation principles and guidelines such as ISPE GAMP 5-Electronic records and electronic signatures requirements (21 CFR Part 11)-IT InterfacesMaintain the Validation Master Plans of Kayentis Solution and Interfaces, and Kayentis business toolsPerform a quality review of development deliverables prior to releaseParticipate in the maintenance and continuous improvement of IT processesMaintain Kayentis risk management and validation processes. Train and Coach teams on Kayentis Quality Management System processes and applicable requirements.Support the following quality processes as applicable to the development and IT processes:-Internal and client audits-Qualification, monitoring and audits of applicable suppliers and subcontractors-Validation of computerized systemsYOUR PROFILE:Master degree level or equivalent in quality, risk management, or software engineeringProfessional experience > 5 years in life science or medical technology developmentExcellent collaborative skillsGood verbal communication and writing skills in French and EnglishCustomer-orientedInterest in team leadership or prior experience in coaching or managing others is a strong assetPreferred:Experience in the pharmaceutical, medical device, or clinical fieldExperience with risk management standards such as ISO14971Experience with GAMP 5 guidelines or 21CFR Part 11 implementationYOUR BENEFITS :Flexible working hoursBonusesMeal vouchersBike allowanceThank you for applying via LinkedIn rather than by email, as it ensures optimal processing of your application
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il y a 2 jours
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