Quality Assurance Associate

　　Location France

　　Requisition ID 2221

　　# of openings 1

　　Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1265)

　　Job Brief

　　Quality Assurance Associate - 12 Months Contract

　　Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

　　Position Summary

　　· Within Amicus Therapeutics French affiliate, reporting to the Head Pharmacist, the 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:

　　Within Amicus Therapeutics' French affiliate, reporting to the Head Pharmacist, the main roles and responsibilities of the Quality Assurance Associate will be :

　　· 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 sales representatives.

　　· 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 or Engineer with a Master 2 in Pharmaceutical Product Quality

　　Professional Work Experience Requirements

　　· 2 years of experience in the quality department of an “exploitant” site.

　　Experience and Skills

　　· Good level of English (speaking, reading and writing)

　　· You have a good command of the Office pack (Word, Excel, etc.).

　　· You will be 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.

　　Travel

　　· Rare travel required.

　　We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

　　Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

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