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Clinical Labs Quality Specialist
il y a 1 mois
Our client located in Rixensart is looking for support in Quality for their clinical laboratory. Ensure the follow up, quality support for the lifecycle of Clinical Laboratory assays and to manage the human biological samples logistics and testing for Laboratory activities. Ensure that business processes are well controlled (in place and in use) and, clinical assays are developed, qualified, or validated in compliance with applicable internal requirements. Review and approve deviations/CAPA and Change Controls linked to assays and HBS activities (including equipment. Review assay SOPs, method qualification and validation documentation as per processes and following good documentation practices. Identify quality risks and opportunities and escalate them as appropriate. Ensure regular Spotchecks in the labs to see if procedures are well applied by business and manage new identified risk or issue as relevant. Be the quality representative in multidisciplinary meetings. Make sure that Records, Standard Operating Procedures, and documentation has been completed and endorsed by the staff authorized to do so. University degree in Sciences (Bio Engineering, Biology, Chemistry…) Good technical and analytical Biological Testing knowledge is an asset. Knowledge in quality regulation and standard requirements covering GCLP/GCP/GLP/including ISO 9001 if possible. In depth knowledge and expertise of quality systems, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA. Management of laboratory Equipment is an asset. SAP and Veeva previous experience are an asset. Good communication skills Good knowledge of English (read, spoken, and written) Ability to manage time and priorities. Minimum 2 to 5 years of experiment Jefferson Wells offers you a permanent contract as a consultant with... Logistics, Universities, Expertise, Assays, Documentation, Chemistry, Iso 9001, Science, Bioengineering, Biology, Business, Communication, Spot checks, Asset, Clinical laboratory, Validation, SAP, Investigations, Testing laboratory, Regulation, Training, GLP, Quality systems, Quality Support, Veeva, Testing, Change Control, Business Process, CAPA Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job https://bit.ly/2jPYsZC For similar jobs, information on employers and career tips visit StepStone.be La version originale de cette offre d'emploi est disponible sur stepstone.be – Créez maintenant votre Job Agent sur StepStone et trouvez le job de vos rêves https://bit.ly/2jPYsZC Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrière sur stepstone.be
