{"id":3738,"date":"2022-05-20T10:37:12","date_gmt":"2022-05-20T08:37:12","guid":{"rendered":"https:\/\/www.b2c-consulting.com\/job\/csv-expert-computer-system-validation\/"},"modified":"2022-08-22T10:13:33","modified_gmt":"2022-08-22T08:13:33","slug":"csv-expert-computer-system-validation","status":"publish","type":"job","link":"https:\/\/www.b2c-consulting.com\/en\/job\/csv-expert-computer-system-validation\/","title":{"rendered":"CSV Expert – Computer System Validation"},"content":{"rendered":"\t\t
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\n\t\t\t\t\t\t20 May 2022\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tLieu\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tR\u00e9gion de Li\u00e8ge<\/span>\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Cat\u00e9gorie du m\u00e9tier :<\/strong><\/p>

Engineering<\/p>

\u00a0<\/p>

Secteur d\u2019activit\u00e9 :<\/strong><\/p>

Notre client est une entreprise\u00a0Biotech belg<\/span>e<\/b><\/span>, active dans plus de 100 pays dans le monde, qui offre \u00e0 ses partenaires un \u00e9ventail de services en mati\u00e8re de recherche, d\u00e9veloppement et production<\/span><\/strong>.<\/span><\/p>

\u00a0<\/p>

Lieu d\u2019activit\u00e9 :<\/strong><\/p>

R\u00e9gion de Li\u00e8ge<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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Votre mission\u202f: <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Dans le d\u00e9partement Validation<\/b><\/span>, v<\/span><\/span><\/span>ous p<\/span>articipez aux r\u00e9unions de suivi des projets<\/span><\/strong> et programmez de mani\u00e8re appropri\u00e9e les activit\u00e9s CSV li\u00e9es aux nouveaux \u00e9quipements\/syst\u00e8mes<\/span><\/strong> \u00e0 qualifier\/valider.<\/p>\r\n

<\/p>\r\n

Vous vous impliquez et participez d\u00e8s le d\u00e9but au lancement des projets<\/span><\/strong> et donnez votre avis sur les pr\u00e9-requis n\u00e9cessaires aux activit\u00e9s de CSV<\/span><\/strong>. Vous r\u00e9digez et\/ou r\u00e9visez les <\/span>documents de qualification\/validation <\/span><\/strong>(URS, analyses de risques, protocoles, rapports, …) pour les \u00e9quipements de production et de contr\u00f4le qualit\u00e9.<\/span><\/p>\r\n

 <\/span><\/p>\r\n

Vos t\u00e2ches<\/b><\/span> : <\/span><\/p>\r\n

    \r\n
  • Ex\u00e9cuter les tests CSV sur les \u00e9quipements de production et de contr\u00f4le qualit\u00e9.<\/li>\r\n
  • Le cas \u00e9ch\u00e9ant : g\u00e9rer, r\u00e9diger, investiguer et suivre les d\u00e9viations li\u00e9es aux sujets CSV ;  r\u00e9diger des SOP ou des instructions de travail relatives aux activit\u00e9s CSV ; fournir des informations sur le statut CSV des \u00e9quipements\/syst\u00e8mes lors des mises \u00e0 jour des DVP des diff\u00e9rentes entit\u00e9s de production et de contr\u00f4le.<\/li>\r\n
  • Agir en tant que PME lors des inspections\/audits des autorit\u00e9s et des clients pour les sujets relatifs \u00e0 la CSV.<\/li>\r\n
  • \u00catre capable de trouver le bon \u00e9quilibre entre la qualit\u00e9, le rendement, la s\u00e9curit\u00e9 et le co\u00fbt.<\/li>\r\n
  • Suivre les formations n\u00e9cessaires pour remplir les exigences de la fonction<\/li>\r\n
  • Participer activement \u00e0 l’am\u00e9lioration continue des activit\u00e9s de l’usine<\/li>\r\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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    Votre profil\u202f:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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      \r\n
    • Ing\u00e9nieur avec 5 ans d’exp\u00e9rience <\/span>en tant qu’expert en validation de syst\u00e8mes informatiques de contr\u00f4le de processus\/automatisation<\/li>\r\n
    • Gestion de projet<\/span><\/strong><\/li>\r\n
    • R\u00e9vision p\u00e9riodique<\/li>\r\n
    • Evaluation <\/span>CSV<\/span><\/strong> <\/span><\/li>\r\n
    • Vous poss\u00e9dez de bonnes comp\u00e9tences en gestion de projet<\/span> : organisation, co\u00fbt, temps, calendrier, contractualisation, approvisionnement, qualification, validation, technologie<\/li>\r\n
    • Vous parlez fran\u00e7ais couramment et pouvez converser en anglais<\/span><\/strong> (lire-\u00e9crire)<\/li>\r\n<\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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      Connaissances sp\u00e9cifiques :<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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      • Gestion de projet<\/li>
      • R\u00e9vision p\u00e9riodique<\/li>
      • Gestion du changement<\/li>
      • \u00c9valuation des CSV<\/li>
      • BPF<\/li>
      • Volume Eudralex Annexe 11 et 15<\/li>
      • 21 CFR Partie 210-211<\/li>
      • GAMP5<\/li>
      • 21 CFR Partie 11<\/li>
      • Automatisation (PLC, SCADA, instrumentation)<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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        Notre offre :<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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        Un\u00a0contrat \u00e0 dur\u00e9e ind\u00e9termin\u00e9e<\/strong><\/span>\u00a0assorti d\u2019un\u00a0salaire \u00e0 hauteur de vos comp\u00e9tences<\/strong><\/span>\u00a0et un package d\u2019avantages extra l\u00e9gaux compos\u00e9, notamment de :<\/p>

        • voiture de soci\u00e9t\u00e9 avec carte carburant<\/li>
        • abonnement GSM<\/li>
        • PC portable<\/li>
        • ch\u00e8que repas, \u00e9coch\u00e8ques<\/li>
        • assurance hospitalisation, assurance groupe<\/li><\/ul>

          \u00a0<\/p>

          Et ce, dans un environnement de travail de\u00a0qualit\u00e9<\/strong><\/span>\u00a0et\u00a0motivant<\/strong><\/span>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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          Int\u00e9ress\u00e9(e) ?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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          Faites-nous parvenir votre candidature.<\/strong><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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          \n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

          Notre client est une entreprise\u00a0Biotech belge, active dans plus de 100 pays dans le monde, qui offre \u00e0 ses partenaires un \u00e9ventail de services en mati\u00e8re de recherche, d\u00e9veloppement et production.<\/p>\n","protected":false},"featured_media":2510,"template":"","meta":{"_acf_changed":false,"footnotes":""},"cat-job":[29],"class_list":["post-3738","job","type-job","status-publish","has-post-thumbnail","hentry","cat-job-region-de-liege","entry"],"acf":[],"yoast_head":"\nCSV Expert - Computer System Validation - B2C Consulting<\/title>\n<meta name=\"description\" content=\"Postulez d\u00e8s maintenant \u2713 Offre d'emploi CSV Expert - Computer System Validation - R\u00e9gion de Li\u00e8ge. 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