{"id":8909,"date":"2023-11-06T11:45:52","date_gmt":"2023-11-06T10:45:52","guid":{"rendered":"https:\/\/www.innov-ia.com\/?post_type=job_listing&#038;p=8909"},"modified":"2023-12-20T08:41:43","modified_gmt":"2023-12-20T07:41:43","slug":"une-responsable-qualite-activites-pharmaceutiques","status":"expired","type":"job_listing","link":"https:\/\/www.innov-ia.com\/fr\/?post_type=job_listing&p=8909","title":{"rendered":"Un(e) Responsable Qualit\u00e9 activit\u00e9s pharmaceutiques"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1300px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-text-transform:none;\"><p>INNOV\u2019IA, leader europ\u00e9en dans le d\u00e9veloppement et la fabrication \u00e0 fa\u00e7on d&rsquo;ingr\u00e9dients sous forme de poudre (poudre instant &#8211; ingr\u00e9dients granul\u00e9s &#8211; microcapsules ), destin\u00e9s aux march\u00e9s de l&rsquo;alimentation humaine ou animale, de la cosm\u00e9tique, de la pharmacie et de la chimie fine, recherche<\/p>\n<p style=\"text-align: center;\"><strong>un(e) Responsable Qualit\u00e9 activit\u00e9s pharmaceutiques<\/strong><br \/>\n<strong>en CDI statut cadre au forfait \u00e0 temps plein, bas\u00e9(e) sur La Rochelle (17)<\/strong><\/p>\n<p><strong>Votre profil<\/strong> : Vous savez vous adapter, vous \u00eates autonome, rigoureux(se), organis\u00e9(e) et savez g\u00e9rer vos priorit\u00e9s. Vous parlez anglais ais\u00e9ment. Vous avez su d\u00e9velopper de bonnes capacit\u00e9s de gestion de projet et savez structurer les approches qualit\u00e9 associ\u00e9es aux MPUP (Mati\u00e8res Premi\u00e8res \u00e0 Usage Pharmaceutiques), en apportant de la clart\u00e9 et de la vision sur les exigences. Vous disposez d\u2019un raisonnement scientifique qui vous permet d\u2019\u00e9tablir des rationnels qualit\u00e9 en prenant en compte les exigences r\u00e9glementaires et clients. Vous savez f\u00e9d\u00e9rer et aimez le travail en \u00e9quipe et avez le sens des responsabilit\u00e9s.<br \/>\nVous exercez vos fonctions sous la Responsabilit\u00e9 de la Direction Usine de La Rochelle<\/p>\n<p><strong>Vos missions principales<\/strong> seront (non exhaustive) :<br \/>\n\u2022 <em>D\u00e9ployer les BPF sur les productions de MPUP (Mati\u00e8res Premi\u00e8res \u00e0 Usage Pharmaceutiques)<\/em><br \/>\no Assure la mise en \u0153uvre des bonnes pratiques de fabrication (BPF chapitre 2) des produits pharmaceutiques fabriqu\u00e9s sur less site.<br \/>\no Etablit les protocoles de validation des proc\u00e9d\u00e9s et assure le suivi des validations<br \/>\no Etablit et tient \u00e0 jour la documentation qualit\u00e9 sp\u00e9cifique \u00e0 la r\u00e9alisation des MPUP.<br \/>\no R\u00e9alise les analyses de risques associ\u00e9es aux fabrications des MPUP, en coordination avec les services R&amp;I, Production, Techniques.<br \/>\no Anime le syst\u00e8me qualit\u00e9 en place lors de fabrications des MPUP.<br \/>\no Etablit les cartes de contr\u00f4le des mati\u00e8res premi\u00e8res, produits en cours de fabrication, produits finis pour les MPUP.<br \/>\no Coordonne la r\u00e9alisation des analyses des MPUP aux diff\u00e9rents stades de leur fabrication avec le laboratoire CQ et les prestataires.<br \/>\no Assure la revue des dossiers de fabrication des MPUP avant et apr\u00e8s fabrication. Lib\u00e8re les mati\u00e8res premi\u00e8res et produits finis associ\u00e9s aux MPUP dans les d\u00e9lais standards<br \/>\no R\u00e9alise les revues qualit\u00e9 produit selon le planning \u00e9tabli en conformit\u00e9 avec les exigences BPF.<br \/>\no Anime et supervise la gestion des changements li\u00e9s aux productions de MPUP<br \/>\n\u2022 <em>Assurer la performance qualit\u00e9<\/em><br \/>\no Suit les indicateurs qualit\u00e9 associ\u00e9s aux MPUP et r\u00e9alise un reporting mensuel et annuel.<br \/>\no R\u00e9alise les audits internes de son p\u00e9rim\u00e8tre et assure le suivi des CAPA associ\u00e9es<br \/>\no Analyse et pr\u00e9sente les tendances et les d\u00e9rives qualit\u00e9. Propose en coordination avec les autres services des actions correctives pour faire progresser la qualit\u00e9 et la performance des installations.<br \/>\no Enregistre analyse et assure le suivi des non-conformit\u00e9s internes et des actions correctives et pr\u00e9ventives associ\u00e9es<br \/>\no Con\u00e7oit et anime des modules de formations sp\u00e9cifiques au d\u00e9ploiement des bonnes pratiques sur son p\u00e9rim\u00e8tre<br \/>\no Propose des actions de simplification et optimisation des pratiques dans une recherche permanente d\u2019efficacit\u00e9 et d\u2019efficience.<br \/>\n\u2022 <em>Relation avec les clients<\/em><br \/>\no Assure la communication avec les clients de MPUP sur l\u2019ensemble des aspects qualit\u00e9, en relation avec le service commercial<br \/>\no Participe \u00e0 l\u2019\u00e9laboration et \u00e0 la revue des cahiers des charges clients pour les MPUP.<br \/>\no Enregistre, analyse et assure le suivi des r\u00e9clamations clients<br \/>\no Repr\u00e9sente INNOV\u2019IA et assure le bon d\u00e9roulement des audits clients<br \/>\no Coordonne le d\u00e9ploiement de la proc\u00e9dure de rappel de lot.<br \/>\n\u2022 Relation avec les autorit\u00e9s de sant\u00e9<br \/>\no Repr\u00e9sente et assure le bon d\u00e9roulement des inspections en coordination avec la Direction Qualit\u00e9.<br \/>\no D\u00e9ploie une approche \u00ab inspection readiness \u00bb sur le site<br \/>\no R\u00e9alise les d\u00e9clarations annuelles d\u2019activit\u00e9 aupr\u00e8s des autorit\u00e9s de sant\u00e9.<\/p>\n<p><strong>Formation<\/strong> :<br \/>\n\u25cf Bac + 5 technique avec exp\u00e9rience de la qualit\u00e9 dans un site de fabrication de MPUP<\/p>\n<p>Candidature \u00e0 adresser \u00e0 la Directrice des Ressources Humaines : tiphaine.hareng@innov-ia.com<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"author":15,"featured_media":0,"template":"","meta":{"_acf_changed":false,"_promoted":"","_job_location":"La Rochelle (17)","_application":"","_company_name":"INNOV'IA","_company_website":"https:\/\/www.innov-ia.com\/","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[86],"job-types":[113],"class_list":["post-8909","job_listing","type-job_listing","status-expired","hentry","job-type-cdi"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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