Pharmaceutical Affairs Manager/Deputy Responsible Pharmacist Role in France

il y a 4 semaines


Paris, Île-de-France Ultragenyx Pharmaceutical Temps plein

Position Overview:

This role is focused on managing the quality system and ensuring compliance with applicable pharmaceutical regulations for the French & Benelux cluster.

As a Pharmaceutical Affairs Manager/Deputy Responsible Pharmacist, you will work closely with the Responsible Pharmacist & Director of Pharmaceutical Affairs France & Benelux to ensure the quality and compliance of our products.

Key Responsibilities:

  • Manage and maintain the Quality System for the Cluster
  • Ensure compliance of promotional activities to applicable standards
  • Definition, implementation, monitoring of audits plan and monitoring of subcontractors involved in pharmaceutical activities
  • Ensure readiness for Inspections by competent authorities or audits
  • Process and track deviations, change controls, risk assessments, CAPAs, recalls and product returns, batch tracking
  • Review packaging materials, promotional and non-promotional materials
  • Coordinate initial and continuous training for employees
  • Serve as a backup for additional responsibilities the Pharmaceutical Affairs department
  • Act as Deputy Responsible Pharmacist to cover periods when the Responsible Person is unavailable

Requirements:

  • Pharmacist diploma, with fluent French and English language skills
  • Qualification as Deputy Responsible Pharmacist and at least 2 years' experience in that role
  • 5-10 years' experience in Quality Assurance
  • 6-12 months experience in Pharmacovigilance and batches follow up
  • Knowledge of GxP's, with a high focus on French and European regulations, GMP, GDP and GVP

Travel



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