Quality Assurance Associate

Quality Assurance Associate

Amicus Therapeutics

Paris, France

Position Summary:

Quality Assurance Associate will be involved in a wide range of activities related to quality assurance of a “exploitant” site and to promotional information certification. As part of a small, dynamic team, these various tasks will enable the Quality Assurance Associate to acquire the skills needed to become a deputy Head Pharmacist.

Roles and Responsibilities:

Quality Assurance:

  • Participate in the implementation of the quality system of the “exploitant” site
  • Write and revise procedures in connection with Pharmaceutical Affairs
  • Monitor internal and supplier deviations
  • Manage and develop relations with the wholesaler distribution partner and the head office
  • Manage product quality and service complaints
  • Participate in audits and implement corrective and preventive actions
  • Monitor stocks and anticipate the risk of shortage
  • Report any shortages risk to the French health authorities
  • Participate in the implementation of shortage management plans
  • Participate in batch recalls and mock recalls
  • Implement quality-related IT tools to improve internal processes

Promotional information charter:

  • Involve in matters relating to the Promotional Information Charter
  • Preparing internal audits and certification audits of promotional information activities
  • Training commercial team

Cross-functional activities:

  • Provide support to activities related to launch of new products
  • Prepare for ANSM inspections and help to implement corrective and preventive actions

Requirements

Educational Requirements:

  • Pharmacist with a Master 2 in Pharmaceutical Product Quality

Professional Work Experience Requirements:

  • Relevant level of experience in the quality department of an “exploitant” site

Experience and Skills:

  • Good level of English (speaking, reading and writing)
  • Good command of the Office pack (Word, Excel, etc.)
  • Rigorous and versatile, with good interpersonal skills and the ability to write, analyse and organise

Other skills/Attributes:

  • Demonstrated alignment with Amicus Mission Focus Behaviors.
  • Passion for rare disease and patient focused.
  • You are curious and enjoy working on a variety of activities.

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