Ingénieur AQ Operationnelle H/F - CDD de 4 mois

Le site GSK Evreux recherche un Ingénieur Assurance Qualité Opérationnelle H/F dans le cadre d'un contrat à durée déterminée de 4 mois.

En tant qu'Ingénieur AQ Opérationnelle, vous assurerez la qualité opérationnelle sur le terrain pour garantir la conformité des opérations de fabrication aux bonnes pratiques. Vous travaillerez au plus près des équipes de production, contrôle qualité et assurance qualité site.

Responsabilités :

- Assurer la surveillance qualité sur le terrain pendant les équipes de production et remonter les risques immédiatement.
- Réviser et contribuer à la libération des lots dans votre périmètre de délégation.
- Mener ou soutenir les investigations d’incidents, de déviations, et de résultats hors spécification ou hors tendance.
- Participer aux audits internes et contribuer à la préparation des inspections externes.
- Suivre, vérifier et documenter l’efficacité des actions correctives et préventives (CAPA).
- Conduire ou soutenir des actions d’amélioration continue et partager les bonnes pratiques opérationnelles.

Profil recherché :

- Diplôme en pharmacie, ou ingénierie (type chimie, biologie) ou qualification professionnelle équivalente.
- Minimum 1 an d’expérience en environnement de fabrication appliquant les Bonnes Pratiques de Fabrication (BPF).
- Expérience pratique en revue de dossiers de lot et activités de libération.
- Expérience en conduite d’investigations de déviations, incidents ou OOS/OOT et suivi de CAPA.
- Excellente communication orale et écrite en français.
- Sens du terrain, rigueur et capacité à prendre des décisions rapides et basées sur des preuves.

Les connaissances et compétences ci-dessous seraient un plus pour votre candidature :
- Expérience préalable en assurance qualité opérationnelle sur un grand site de production.
- Compétences en audit interne et préparation aux inspections réglementaires.
- Connaissance des systèmes de gestion documentaire et d’ERP (par exemple Veeva, SAP).
- Expérience de projets d’amélioration continue et d’analyse de données qualité.
 

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Fr-diversity.recruitment@gsk.com​

Please note should your enquiry not relate to adjustments; we will not be able to support you through these channels.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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