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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