Pharmacien de Site : AQ & Compliance
TYPE
Full Time / CDI
REFERENCE
748275
LOCATION
Nouvelle Aquitaine - Sur site
Description
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This is a great space to write a long text about your company and your services. You can use this space to go into a little more detail about your company. Talk about your team and what services you provide. Tell your visitors the story of how you came up with the idea for your business and what makes you different from your competitors. Make your company stand out and show your visitors who you are.
What you will do
I'm a paragraph. Click here to add your own text and edit me. It’s easy. Just click “Edit Text” or double click me to add your own content and make changes to the font. Feel free to drag and drop me anywhere you like on your page. I’m a great place for you to tell a story and let your users know a little more about you.
This is a great space to write a long text about your company and your services. You can use this space to go into a little more detail about your company. Talk about your team and what services you provide. Tell your visitors the story of how you came up with the idea for your business and what makes you different from your competitors. Make your company stand out and show your visitors who you are.
Who you are
I'm a paragraph. Click here to add your own text and edit me. It’s easy. Just click “Edit Text” or double click me to add your own content and make changes to the font. Feel free to drag and drop me anywhere you like on your page. I’m a great place for you to tell a story and let your users know a little more about you.
This is a great space to write a long text about your company and your services. You can use this space to go into a little more detail about your company. Talk about your team and what services you provide. Tell your visitors the story of how you came up with the idea for your business and what makes you different from your competitors. Make your company stand out and show your visitors who you are.
What they offer
I'm a paragraph. Click here to add your own text and edit me. It’s easy. Just click “Edit Text” or double click me to add your own content and make changes to the font. Feel free to drag and drop me anywhere you like on your page. I’m a great place for you to tell a story and let your users know a little more about you.
This is a great space to write a long text about your company and your services. You can use this space to go into a little more detail about your company. Talk about your team and what services you provide. Tell your visitors the story of how you came up with the idea for your business and what makes you different from your competitors. Make your company stand out and show your visitors who you are.
Got what it takes?
About the job
Au sein d’une CDMO travaillant sur la production de lots de produits stériles spécialisés dans des lots pour des essais cliniques, ou de petits volumes notamment pour des Maladies Rare crée un environnement avec une diversité importante.
Vous intégrerez un site d’une Quarantaine de personne qui vous donnera facilement la visibilité de celui-ci et des différents collaborateurs avec lesquels vous allez évoluer. Cela vous permettre d’être proche du terrain, de conserver la partie opérationnelle dans certains cas tout en ayant les responsabilités stratégiques.
Cette vue d’ensemble est importante et peut vous ouvrir un panel d’opportunité dans la suite de votre carrière.
En tant que Pharmacien de Site, vous devez être enregistré comme Pharmacien Adjoint et Thésé pour la prise des responsabilités Pharmaceutiques.
Your missions
• Mise en place et gestion de la stratégie Qualité et compliance sur le site de production.
• Mettre en place la stratégie de Validation des procédés et son déploiement sur le site.
• Assurer et certifier les médicaments fabriqués sur le site (Libération de lots).
• Analyse des Déviations, OOS, CC, CAPA et diagnostiquer leurs causes.
• Gestion des réclamations clients.
• Gestion et suivi des Audits sur le site de production.
• Management en direct d’une petite équipe Qualité : QMS, Auditeur, Lean…
Your Experience
• Vous êtes Pharmacien Thésé (Pharm D.) inscriptible à l’ordre en tant que Pharmacien Délégué de site.
• Vous avez 4-5 années d’expérience sur un site de Production avec des responsabilités similaires.
• Vous avez une maitrise complète des BPF & BPD (GMP & GDP).
• Une expérience sur des injectables ou en milieu Stérile est un gros plus.
• Vous parlez Français et Anglais.
