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Open nowFirst seen 81 days ago

Pharmacien Libérateur H/F

Cryoport Inc.26 open roles

Where
Pont-Du-Chateau, France
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Your applicationOpen nowPharmacien Libérateur H/FCryoport Inc. · Pont-Du-Chateau, France
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The clock on this job

Early applications get read.

13.5% of postings close within 7 days. Measured by our own scanner across the market. Cryoport Inc. postings stay open a median of 66 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.6%3 days
  3. 13.5%7 days
  4. 21.8%14 days
  5. 36.6%30 days
  6. 58.9%60 days
This job: first seen 81 days ago

Cryoport Inc. median: 66 days open

The posting

Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.

Afin d'agrandir notre équipe pharmaceutique France, nous recrutons un Pharmacien Libérateur H/F pour le site de Pont-Du-Château (63).

Pris de poste souhaitée: dès que possible.

Rémunération: selon profil

  • Responsabilités et missions:

Assurer la revue et l’examen des dossiers de lots conformément aux BPF, aux dossiers d’AMM et aux exigences clients.

Réaliser la libération pharmaceutique des lots, par délégation du Pharmacien Responsable, après analyse de la documentation et vérification de la conformité.

Garantir la conformité des produits fabriqués, en s’assurant du respect des normes en vigueur avant mise sur le marché.

Participer à la gestion des déviations, non-conformités, réclamations, et conduire des investigations pour définir les actions correctives et préventives (CAPA).

Rédiger et mettre à jour la documentation qualité, incluant procédures, revues qualité produits, rapports d’audit, documents contractuels.

Participer aux audits internes et externes (préparation, conduite, rédaction des rapports).

Échanger avec les autorités compétentes (ex. ANSM) concernant la déclaration de défauts qualité.

Contribuer à la formation et sensibilisation du personnel aux exigences qualité et réglementaires.

Etre le PRI et/ou le pharmacien délégué interimaire du/des sites de l’établissement pharmaceutique

  • Activités principales:

Revue des dossiers de lots et certification documentaire.

Suivi qualité des activités de production et support aux équipes opérationnelles.

Participation aux lancements de nouveaux produits.

Gestion des CAPA et des changements.

Réalisation ou contribution aux auto‑inspections et audits incluant des déplacments en France et à l’étranger

Évaluation des risques qualité et contribution à l’amélioration continue.

  • Compétences requises:

Docteur en Pharmacie, inscriptible à l’Ordre des Pharmaciens – Section B (obligatoire).

Expérience dans la liberation de lot ou dans un établissement pharmaceutique MTI, au moins 2 ans.

Expérience en assurance qualité opérationnelle et/ou en environnement industriel pharmaceutique entre 3 et 5 ans.

Docteur en Pharmacie, inscriptible à l’Ordre des Pharmaciens – Section B (obligatoire).

  • Communication et langues:

Maitrise de l’anglais lu, écrit et parlé

  • Autres compétences requises:

Capacité à travailler dans un cadre réglementaire exigeant et en évolution.

Aisance dans la rédaction de documents techniques.

Capacité à évaluer la criticité des anomalies et à prendre des décisions adaptées.

Sens de l’amélioration continue et démarche qualité

  • Environnement de travail:

Responsabilité rattachée au Pharmacien Responsable.

Travail en collaboration étroite avec la production, logistique, le contrôle qualité, les équipes transverses et parfois les autorités de santé.

Environnement dynamique, rythmé par les impératifs de conformité, d’investigations et d’amélioration continue

Environ 10 audits par an seront à effectuer (France et hors France).

Astreintes pharmaceutiques.

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