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**Quality Assurance Associate - 12 month 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**
The Quality Assurance Associate will be involved in a wide range of activities related to quality assurance of an “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.
- Prepare internal audits and certification audits of promotional information activities.
- Train the commercial team.
- ** Cross-functional Activities**:
- Provide support to activities related to the 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, analyze, and organize.
**Other Skills/Attributes**:
- Demonstrated alignment with Amicus Mission Focus Behaviors.
- Passion for rare disease and patient focus.
- Curious and enjoy working on a variety of activities.
**Travel**:
Limited travel expected.
- 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 drive 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 status, disability status, or any other characteristics protected by applicable federal, state, or local law._
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