Quality Operations Technician

il y a 2 semaines

Gosselies, Belgique Digital Interim Temps plein

**Qui sommes-nous ?**

Digital Intérim : Une agence d’Intérim basée sur l’échange et la collaboration.

Plus qu’une simple agence d’intérim, Digital Intérim vous propose un véritable accompagnement. Pour cela, nous avons mis en place une tripartite (intérimaire, entreprise et Digital Intérim) basée sur l’échange et la collaboration, où la digitalisation renforce un peu plus les contacts humains.

En choisissant Digital Intérim, vous avez alors l’assurance de profiter de services professionnels et de grande qualité

**Définition du profil recherché**:
En tant que Quality Operations technician, vous serez l'interface entre les départements opérationnels et QA.

Vous serez responsable de la revue documentaire, du coaching de l'esprit qualité et de la gestion des situations imprévues afin de garantir la conformité avec les Guidelines, les législations et les demandes des clients.

Vous travaillerez sur le terrain pour répondre aux besoins de la production tout en assurant la conformité.

**Tâches principales**:
Participer à la revue de la documentation de production et analytique avant le release de l'API

Participer à la préparation des dossiers de release de l'API

Être le premier contact de la production pour les aspects QA (déviations, investigation,...)

Assurer la bonne gestion qualité des anomalies rencontrées

Assurer le suivi des actions mises en production dans le cadre de non-conformités rencontrées

Assurer la communication entre la production et les responsables projets QA

Participer à l'amélioration de l'esprit qualité du site en identifiant les mauvaises pratiques et en aidant à leur correction (re-sensibilisation, formation,...)

Participer aux processus d'amélioration continue des processus et procédés en place

Participer à la révision QA des déviations

Participer à la révision QA de nouvelles SOPs/MPDs/modification de SOPs/MPDs

Participer à des audits internes process et système et la rédaction des rapports d'audit

**Profil recherché**:
Bachelier scientifique ou équivalent

Expérience de minimum 2 ans dans un environnement GMP (maîtrise de ICH)

La maîtrise des procédés de synthèses chimiques, de purification et de séchage est un plus

Excellente connaissance du français

Bonne compréhension de l'anglais

Grande précision dans l'exécution des tâches

Rigueur, organisation, flexibilité

Excellent esprit d'équipe

**Savoir-être**:
Flexible, volontaire et constructif.

Excellente capacité de communication et de reporting à la hiérarchie.

Excellente capacité organisationnelle.

Connaissance de base en anglais est un plus.

**Offre**:
Package salarial attractif

Avantages extra-légaux

Poste stimulant dans un environnement innovant, dynamique et à forte progression

**Horaire de travail**:
Travail de jour (8h-16h30)

**Type de contrat**:
Contrat à durée indéterminée (temps plein)

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