Compliance Expert

vor 3 Wochen

Aubonne, Schweiz Merck KGaA Darmstadt Germany Vollzeit

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimageable with us.

**Votre rôle**

L'expert compliance assure la compliance au sein de l'équipe de production, en respectant les cGMPs, et en assurant l'exactitude de la documentation.

Ce rôle est un poste clé dans l'équipe pour maintenir les exigences qualité en participant aux déviations, CAPAs, Change control et la revue documentaire.
- Contrôler et consolider les dossiers de production dans son domaine d'activité (revue finale et transfert au QA)
- Suivi du E2E LT et participation à la réduction du lead time
- Effectuer la déclaration et le suivi de déviation de l'équipe de production
- Participer à la résolution des déviations, CCPs et CAPAs ainsi qu'à des investigations complexes
- Coordonner et assurer le respect des due dates pour les déviations, CCPs et CAPAs de l'équipe
- Participer au traitement des OOTs de l'équipe de production (en tant que back-up)
- Effectuer la préparation, le maintien et la revue des procédures et/ou d'autres documents nécessaires pour maintenir le statut GMP des activités exécutées dans son domaine d'activité à la demande du manager
- Effectuer la rédaction des protocoles et rapports dans son domaine de compétence selon la demande du manager
- Effecuter des Gemba hebdomadaires et des inspections internes avec les managers

**Votre profil**:

- Expérience professionnelle de min 5 ans en qualité (traitement des déviations, change control,..)
- Diplôme en biotech/ pharma/ chimie / sciences de la vie
- Bonnes connaissances des normes GMP et règlementation en vigueur pour la production des principes actifs
- Maitrise des logiciels bureautiques
- Bon niveau rédactionnel
- Faire preuve de rigueur

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

Job Requisition ID: 259483

Location: Aubonne

Career Level: D - Professional (4-9 years)

Working time model: full-time

**North America Disclosure**

**Notice on Fraudulent Job Offers**
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.

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