Release Officer

il y a 1 semaine

Lessines, Wallonie, Belgique BAXTER Temps plein
**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**RESUME DE LA FONCTION**

Le Release officer II revoit les dossiers de lots afin de libérer **des produits finis thérapeutiques** conformes aux exigences réglementaires de leurs pays de destination et alignés avec les besoins et exigences de l'entreprise. Il/elle libère des produits finis de qualité et dans les délais.
Il/elle s'assure que les produits sont libérés sans investigation qualité en cours. Il/elle communique avec différents départements (production, process quality, les laboratoires..)

**TACHES GENERALES**
- Responsable des activités de revue, de complétude et de conformité du dossier de lot, préparant ainsi la certification finale des médicaments à usage humain et vétérinaire par le QP.
- Revoir et confirmer l'adéquation aux normes GMP, GDP, aux SOP locales et aux réglementations des différentes autorités nationales des dossiers de lots.
- Libérer à temps des produits finis tout en en faisant un suivi avec les services internes et externes (achats, QA réception, logistique, production, laboratoires ).
- Libération finale des lots et délivrance des documents appropriés (certificat d'analyse, certificat de conformité...).
- Autonome dans la revue des dossiers de lots et impliqué dans la résolution de problèmes liés à ces dossiers ainsi que la prise de contact avec les personnes nécessaires pour résoudre ces problèmes.
- Mettre à jour le système EBR Elan avec les informations nécessaires à la revue des dossiers de lots
- Gérer la documentation du département release (CoA et CoC); création, publication et archivage.
- Initier des évènements sur ELAN en cas de déviation
- Initier des non-conformités sur Trackwise
- Assister le qualified Person de l'entreprise dans l'exécution de ses taches.
- Résoudre les difficultés auxquelles l'équipe est confrontée afin d'atteindre les objectifs de libération du département.
- Mettre à jour les procédures liées aux activités de libération
- Identifier et soutenir de manière proactive la mise en œuvre d'opportunités d'amélioration continue dans les activités d'assurance qualité.
- Gérer la zone d'archivage du département Release.
- Participer aux activités d'audit internes et externes.
- Participer aux réunions quotidiennes (TIER)
- Revue et Suivi des rapports résultats des tests labo
- Respecter les directives EHS, GDP et GMP.
- Atteindre ses objectifs personnels ainsi que ceux du département release

**PROFIL RECHERCHE**
- Diplôme Bachelier et/ou master en Electromécanique, Chimie, biochimie, biotechnologie ou expérience équivalente
- Vous disposez d'une expérience dans une fonction équivalente de 3 à 5 ans
- Vos domaines d'expertise sont la Qualité et/ou l'industrie pharmaceutique
- Vous maitrisez le Français de manière courante et avez de solides notions en Anglais
- Maitrise de la Suite Office et des logiciels tels que Access, EBR, JDE, TW8, MILD, LIMS, TCU
- Esprit d'équipe
- Capacité d'analyse
- Proactivité, et prise d'initiatives
- Respectueux des règles et des procédures
- Rigoureux, capacité d'organisation et de planification
- Bon communicateur
- Esprit de synthèse et Résolution de problèmes
- Autodidacte et Autonome

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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