{"id":7060231,"date":"2024-11-25T15:18:28","date_gmt":"2024-11-25T15:18:28","guid":{"rendered":"https:\/\/jeffersonwells.be\/vacancies\/25229-sme-qualification-validation\/"},"modified":"2024-11-25T15:18:28","modified_gmt":"2024-11-25T15:18:28","slug":"25229-sme-qualification-validation","status":"publish","type":"matador-job-listings","link":"https:\/\/jeffersonwells.be\/fr\/vacancies\/25229-sme-qualification-validation\/","title":{"rendered":"SME qualification validation"},"content":{"rendered":" <ul class=\"matador-job-meta matador-job-meta-job-7060231 matador-job-meta-default\"> <li class=\"matador-job-meta-field matador-job-field-job_general_location matador-job-field-value-braine-lalleud\"> <span class=\"matador-job-meta-label\">Lieu:<\/span> <span class=\"matador-job-meta-value\">Braine-l&#039;Alleud<\/span> <\/li> <li class=\"matador-job-meta-field matador-job-field-bullhorn_job_id matador-job-field-value-25229\"> <span class=\"matador-job-meta-label\">Travail<\/span> <span class=\"matador-job-meta-value\">#25229<\/span> <\/li> <\/ul> <p><span><span><strong><span>SME Qualification \/ Validation<\/span><\/strong><\/span><\/span><\/p> <p><span><span>Notre client est \u00e0 la recherche d\u2019un nouveau <strong>SME (Subject Matter Expert) Qualification \/ Validation<\/strong> dans le cadre de la <strong>mise en production de nouveaux syst\u00e8mes, proc\u00e9d\u00e9s et \u00e9quipements GMP informatis\u00e9s ou non informatis\u00e9s<\/strong>. La personne aura pour objectif de d\u00e9finir et proposer la strat\u00e9gie de qualification \/ validation pour les syst\u00e8mes, proc\u00e9d\u00e9s et \u00e9quipements. Cela comprend\u00a0:<\/span><\/span><\/p> <ul> <li><span><span>R\u00e9alisation\/Animation des analyses de risques qualit\u00e9.<\/span><\/span> <li><span><span>D\u00e9finition de la strat\u00e9gie de qualification \/ validation en accord avec l\u2019\u00e9quipe projet.<\/span><\/span> <li><span><span>R\u00e9daction du plan de validation et des documents de qualification associ\u00e9s.<\/span><\/span> <li><span><span>Mettre en place une approche efficace et standardis\u00e9e de qualification et de validation des syst\u00e8mes, proc\u00e9d\u00e9s et \u00e9quipements.<\/span><\/span> <\/ul> <p> <span><span><strong><span>R\u00f4le et Responsabilit\u00e9s<\/span><\/strong><\/span><\/span><\/p> <ul> <li><span><span><strong>D\u00e9velopper un partenariat avec les clients internes, les services support internes (IT, M\u00e9trologie, Contr\u00f4le p\u00e9riodique) et les fournisseurs externes.\u00a0 <\/strong><\/span><\/span> <li><span><span><strong>Prendre en charge les projets de qualification \/ validation des syst\u00e8mes, proc\u00e9d\u00e9s et \u00e9quipements qui lui sont confi\u00e9s dans le respect des planning d\u00e9finis\u00a0:<\/strong><\/span><\/span> <\/ul> <ul> <li><span><span>Coordination et suivi des activit\u00e9s de qualification \/ validation confi\u00e9es<\/span><\/span> <li><span><span>Elaboration de la strat\u00e9gie de qualification \/ v\u00e9rification \/ validation<\/span><\/span> <li><span><span>R\u00e9daction des documents de qualification \/ validation<\/span><\/span> <li><span><span>Coordination \/ ex\u00e9cution des tests<\/span><\/span> <li><span><span>Attribution du statut qualifi\u00e9 aux \u00e9quipements<\/span><\/span> <li><span><span>Attribution du statut valid\u00e9 aux proc\u00e9d\u00e9s<\/span><\/span> <\/ul> <ul> <li><span><span><strong>R\u00e9aliser les Periodic Reviews des syst\u00e8mes et \u00e9quipements qui lui qui lui sont confi\u00e9es\u00a0:<\/strong><\/span><\/span> <\/ul> <ul> <li><span><span>Coordination des \u00ab Periodic Review \u00bb sous sa responsabilit\u00e9<\/span><\/span> <li><span><span>Etre garant du respect du planning de \u00ab Periodic Review \u00bb (Requis Compliance)<\/span><\/span> <li><span><span>R\u00e9-\u00e9valuation du statut qualifi\u00e9 des syst\u00e8mes et \u00e9quipements<\/span><\/span> <\/ul> <ul> <li><span><span><strong>R\u00e9daction des rapports GMP et QUALITE<\/strong> :\u00a0 Travailler en collaboration avec le Service \u00ab Quality Assurance \u00bb pour assurer la conformit\u00e9 vis-\u00e0-vis des r\u00e9glementations en vigueur, guidelines, normes et proc\u00e9dures internes (SOP).<\/span><\/span> <li><span><span><strong>Participer aux audits internes, audits externes et Inspections r\u00e9glementaires<\/strong> (autorit\u00e9s nationales, internationales, FDA, EMEA, etc&#8230;).\u00a0\u00a0 <\/span><\/span> <\/ul> <ul> <li><span><span>Reporter \u00e0 sa hi\u00e9rarchie tout probl\u00e8me ayant un impact sur la qualit\u00e9 des syst\u00e8mes, des instruments ou des produits fabriqu\u00e9s et\/ou en d\u00e9veloppement.<\/span><\/span> <\/ul> <p> <span><span><strong><span>Qualifications et comp\u00e9tences requises.<\/span><\/strong><\/span><\/span><\/p> <ul> <li><span><span>Bachelier ou master dans un domaine relevant au poste.<\/span><\/span> <li><span><span>Minimum 3 \u00e0 5 d\u2019exp\u00e9rience dans le scope d\u2019activit\u00e9s.<\/span><\/span> <li><span><span>Une exp\u00e9rience solide en qualification et validation d\u2019\u00e9quipements.<\/span><\/span> <li><span><span>Une exp\u00e9rience dans le secteur pharmaceutique.<\/span><\/span> <li><span><span>Avoir d\u00e9j\u00e0 men\u00e9 \u00e0 bien un projet en rapport avec la qualification\/validation.<\/span><\/span> <\/ul> <p> <span><span><strong><span>Notre Offre<\/span><\/strong><\/span><\/span><br \/> <span><span>A la recherche d\u2019un nouveau d\u00e9fi professionnel\u00a0? Jefferson Wells vous offre un accompagnement, \u00e9tape par \u00e9tape, pour l\u2019accomplissement de votre prochain objectif professionnel. Un contrat en CDI ou une collaboration avec Freelance possible. Une question\u00a0? Un doute\u00a0? Ou tout simplement int\u00e9ress\u00e9-e par le poste\u00a0? Contactez Aylin Ugurlu\u00a0: <a href=\"mailto:aylin.ugurlu@jeffersonwells.be\">aylin.ugurlu@jeffersonwells.be<\/a> .<\/span><\/span><\/p> <nav class=\"matador-job-navigation\"> <ul> <li> <a href=\"https:\/\/jeffersonwells.be\/fr\/vacancies\/25229-sme-qualification-validation\/\" rel=\"button\" class=\"matador-button\" title=\"Appliquer maintenant\">Appliquer maintenant<\/a> <\/li> <\/ul> <\/nav> ","protected":false},"excerpt":{"rendered":"<p>Lieu: Braine-l&#039;Alleud Travail #25229 SME Qualification \/ Validation Notre client est \u00e0 la recherche d\u2019un nouveau SME (Subject Matter Expert) Qualification \/ Validation dans le cadre de la mise en production de nouveaux syst\u00e8mes, proc\u00e9d\u00e9s et \u00e9quipements GMP informatis\u00e9s ou non informatis\u00e9s. La personne aura pour objectif de d\u00e9finir et proposer la strat\u00e9gie de qualification &hellip; <a href=\"https:\/\/jeffersonwells.be\/fr\/vacancies\/25229-sme-qualification-validation\/\" class=\"more-link\">Continuer la lecture<span class=\"screen-reader-text\"> de &laquo;&nbsp;SME qualification validation&nbsp;&raquo;<\/span><\/a><\/p>\n","protected":false},"template":"","meta":{"_matador_source_id":"25229"},"matador-categories":[1420592],"matador-locations":[1420020],"matador-types":[1419976],"matador-provinces":[1420489],"class_list":["post-7060231","matador-job-listings","type-matador-job-listings","status-publish","hentry","matador-categories-life-sciences","matador-locations-braine-lalleud","matador-types-contracting","matador-provinces-walloon-brabant"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>SME qualification validation - Jefferson Wells<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jeffersonwells.be\/vacancies\/25229-sme-qualification-validation\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SME qualification validation - Jefferson Wells\" \/>\n<meta property=\"og:description\" content=\"Lieu: Braine-l&#039;Alleud Travail #25229 SME Qualification \/ Validation Notre client est \u00e0 la recherche d\u2019un nouveau SME (Subject Matter Expert) Qualification \/ Validation dans le cadre de la mise en production de nouveaux syst\u00e8mes, proc\u00e9d\u00e9s et \u00e9quipements GMP informatis\u00e9s ou non informatis\u00e9s. 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