Pharmaceutical Affairs Manager/Deputy Responsible Pharmacist

il y a 2 semaines


Paris, Île-de-France Ultragenyx Pharmaceutical Temps plein
Job Summary:

We are seeking a highly skilled Pharmaceutical Affairs Manager/Deputy Responsible Pharmacist to join our team at Ultragenyx Pharmaceutical. As a key member of our Regulatory Affairs department, you will be responsible for managing the quality system and ensuring compliance with applicable pharmaceutical regulations for the French & Benelux cluster.

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
  • Ensure deviations, change controls, risk assessments, CAPAs, recalls and product returns, batch tracking are processed and tracked accordingly
  • Review packaging materials, promotional and non-promotional materials
  • Coordinate initial and continuous training for employees, including tracking, monitoring of knowledge acquisition and archiving
  • 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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