Jr Engineer, Quality Assurance, LN Requisition ID: 69717 Date: Jul 24, 2025 Location: Le Nouvion, Aisne, FR Department: Quality Description: At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Nous recherchons un(e) Ingénieur Junior, Assurance Qualité pour soutenir les programmes CAPEX de notre usine et s'assurer de leur conformité avec les exigences de qualité. Vous développerez des analyses de données et une approche préventive pour améliorer les stocks bloqués et le Coût de la Mauvaise Qualité (CoPQ). Vous serez également chargé(e) d'une partie des validations qualité et veillerez à ce que le système qualité respecte les normes West et les standards applicables. Vous appuierez les processus de laboratoire afin d'assurer leur conformité aux exigences de qualité. **Tâches et Responsabilités Essentielles :** **P** **rogrammes CAPEX de l'usine :** + Représenter le département qualité au sein des équipes projets. + Assurer la conformité des nouveaux équipements et programmes avec les exigences de qualité. **Amélioration continue :** + Participer aux projets d'amélioration, en visant particulièrement l'amélioration du coût de non Qualité. + Gérer et apporter des améliorations à la gestion des stocks bloqués (produits finis, semi-finis, matières premières). + Analyser les risques : Contribuer au contrôle des risques en participant aux analyses de risques et en proposant des actions. **Gestion des processus qualité :** + Veiller à la définition, la mise en place, la capitalisation et l'efficacité des processus qualité, et proposer des plans d'actions pour améliorer la performance des processus qualité. + Gérer les processus qualité à travers des indicateurs clés de performance (KPI) en Europe et à LN. + Participer à la gestion qualité des fournisseurs. + Audits internes : + Réaliser une partie des audits selon le plan annuel. + Assurer le suivi des audits internes réalisés + participer aux revues Annuelles de Produits pour les produits Westar®. **Validations :** + Participer, si nécessaire, aux validations décrites dans le SVP (expertise sur la méthode, participation aux AMDECs, etc.). + Examiner et approuver les dossiers de validation. **Support au laboratoire :** + Examiner et approuver les écarts du laboratoire. + Examiner et approuver les résultats hors spécifications. **Travail selon les règles GMP :** + Assurer le respect strict des règles et la bonne application des procédures, notamment en matière d'hygiène personnelle, de propreté, de manipulation des produits et de contamination croisée sur les articles mélangés. **Qualifications de Base :** + Diplôme de Master en Ingénierie QA ou formation équivalente avec solide bagage technique. + Première expérience en tant qu'apprenti ou mission de courte durée en AQ industrielle est un atout. **Connaissances, Compétences et Aptitudes Préférées :** + Bonne connaissance des réglementations qualité et BPM. + Maîtrise de l'anglais à l'écrit et à l'oral requise. + Bonne pratique de Microsoft Office et SAP. + Excellentes compétences en communication orale et écrite. + Sens des compétences interpersonnelles et du travail d'équipe. + Bonne présentation générale. + Compétences analytiques et esprit d'initiative requis. **Job Summary** The Jr Assoc, Quality Assurance will support Quality activities within a multi-functional team environment for medical devices. The role will provide analytical support within the Quality team and will assist with projects and tasks in support of business needs and will play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria. The role will also execute transactions in relevant GMP systems (Master Control, SAP, Share Point) and other relevant quality functions as applicable including site audit support. **Essential Duties and Responsibilities** + Assist in structuring and formatting documentation to ensure compliance to procedures, relevant regulations and standards. + Assist teams in the development DHF and DMR documents, specifically in regards to facilitating document control activities. + Work collaboratively with internal customers to refine and optimize analysis and reporting criteria as well as manage expectations around analysis delivery timelines and output capabilities + Assist with tracking, documenting, and reporting quality notification activities including but not limited to Failure Investigations, CAPAs, Non-Conformance assessments, audit findings and deviations. + Support the development of QMS procedures and work instructions. + Work cross-functionally with individuals and project or extended teams to ensure success of projects. + Drive solutions to ensure internal customer related problems/issues are communicated. + Establish routine communication strategies for project tracking and prioritization + Assure escalation of quality related issues to ensure effective remediation + Identify training needs and take action to ensure company wide compliance. + Provide training and support to team members that covers systems, policies, procedures, and core processes. + Liaison with company and customers on Quality matters + Other duties as assigned **Additional Responsibilities** **Education** + Bachelor's Degree Life Science or equivalent. preferred **Work Experience** + No min required 2 years similar experience. preferred **Preferred Knowledge, Skills and Abilities** + Able to be aware of all relevant SOPs as per Company policy and Quality Manual + Able to comply with the company’s safety policy at all times + Able to comply with the company’s quality policy at all times. **License and Certifications** **Travel Requirements** None: No travel required **Physical Requirements** Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. **Additional Requirements** West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.