QA Operation Associate - Pause Nuit

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QA Operation Associate - Pause Nuit

Lessines, Belgium

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Business Area Overview

The Europe & Canada (EUCAN) Business unit supports Takeda's mission at a regional level and as the leader in rare diseases and specialty care, we champion better health and a brighter future for patients, healthcare providers and our people.

Across the EUCAN BU, patients come first in every decision we make. We develop strategic partnerships which deliver value for society and create a culture within which our people can thrive and reach their full potential.

Our mission is to empower and enable our people to fulfill their potential by embracing diversity and creating a high-performance, collaborative working environment. In the EUCAN region integrity is one of our key values. We put patients, trust and reputation before business and this is one of the main reasons why our people choose to work here.

Success Profile

What makes a successful team member within EUCAN at Takeda?

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

I know that I need to work in a place where I can grow and be challenged, and what motivates me the most is to make a difference. I think what we offer here at Takeda truly helps patients. And it’s important to bring others along on that journey.

Rebecca Yu VP of Patient Value & Access

Believe in your own ability to do the things you want to do. If you do that, things will happen.

Heena Howitt Country Medical Lead Genetic Diseases

The faster we help someone get a true diagnosis of their underlying condition, the faster we can offer a treatment that can help them get back to living their life and improve their future outlook

Christian Downton Business Unit Director Rare Metabolic Diseases

Working at Takeda

  • Inclusive

    Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 16 companies to receive Top Global Employer® status for 2021.

  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

QA Operation Associate - Pause Nuit

Job ID R0033575 Date posted Aug. 13, 2021 Location Lessines, Belgium

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Job Description

  • Tâches:
  • Assurer la presence qualité sur le terrain pour le suivi des opérations de production liée au activités de remplissage aseptique, y compris les activités préparatoires et de sterilization.
  • Assurer une présence quotidienne (en shift) en zone afin d’assurer l’application des GMP, GDP, la conformité des procédures, des pratiques aseptiques, et tous les aspects liés à la fiabilité et la cohérence des opérations.
  • Être le premier point de contact en cas d’issue qualité et fournir un support et une expertise en relation avec les problèmes Qualité en zone en collaboration avec le Manufacturing..
  • Participer aux interventions de maintenance ayant lieu en zone aseptique et assesser les remises en état éventuelles en collaboration avec le manufacturing
  • Participer au programme d’observation afin de s’assurer que toutes les étapes du process (y compris le montage, le testing et le cleaning sont bien effectués correctement
  • Responsable de la revue qualité des dossiers de production (papier et EBM) pour les opérations liées au filling, sterilisation, set up, cleaning. (revue sur le terrain à developer)
  • Suivi du planning et révision des requalifications standard de l’équipement / système (stérilisation, dépyro, smoke tests, Emeri tests, …).
  • Approuver les changements documentaires des SOP, RS et form lié au filling.
  • Participer à la production de routine des media fills par planning établi en collaboration avec le service Manufacturing.
  • Donner la formation inspection visuelle des gants
  • Donner du support en cas de grosses investigations
  • Profil:
  • Bachelier en sciences, ( Engineering/Technique, Chimie, Biochimie, Biologie, Agronomie (3-4 ans de formation)
  • Connaissances de procédés aseptique et qualité ainsi que des réglementation (FDA, Eudralex, …)
  • Expérience de 3 ans en production/ qualité
  • Esprit critique et capacité à prendre des décisions rapides
  • Bonne collaboration et esprit d’équipe
  • Assertivité
  • Flexibilité et autonomie
  • Capacité de communiquer de manière efficace et à résumer correctement les différentes information
  • Orienté data et fait pour prendre les décisions
  • Bonne organisation

Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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We take action by focusing on our four priorities

  • Create an exceptional people experience
  • Responsibly translate science into highly innovative, life-changing medicines and vaccines
  • Protect our planet
  • Unleash the power of data and digital

About our location

Lessines, Wallonia

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