Quality Assurance Officer
Il y a 2 mois
AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Denmark, Sweden, UK, Romania, US, and Czech Republic.
The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials for immuno-oncology and cell & gene therapies, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.
We are currently looking for an enthusiastic and talented Quality Assurance Officer. This role can be home-based anywhere France and may require a partially remote / hybrid in-office schedule in if the Paris area.
PURPOSE AND MAIN RESPONSIBILITIES
Purpose
In an international team of 10 people, be an actor under the direction of the Senior GCP Quality Assurance Manager in maintaining the Quality Assurance System for the activities carried out by the Company in the field of Clinical Trials in order to meet regulatory requirements, applicable procedures, international regulations on clinical trials, Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GPP).
**Involvement mainly in**:
- The implementation and maintenance of the Quality Assurance System (non-conformities, deviations, quality plans, audit plans) / Document System (writing & review SOPs, Instructions, Templates and other quality documents.
- Regulatory monitoring within the framework of regulations and Good Practices applicable at local and international level.
- The preparation ofinternal audits and audits carried out by customers and the implementation and monitoring of CAPAS.
- Preparation of inspections and post-inspection follow-up
- The mastery of suppliers (referencing, qualification, monitoring).
**Qualifications and skills required**:
- Master 2 in Quality Assurance level with at least 2 years of experience in Quality Assurance under Good Clinical Practices in addition to aprofessional experience in the Field of Clinical Trials
- Sense of responsibility
- Rigor precision
- Proactivity
- Spirit of analysis, synthesis and writing
- Ability to work in a team and listen
- Pedagogy and good communication
**Languages**:
**o English**: proficiency with reading, writing and speaking (C1 level required)
**Additional**: position is based in Paris region, France. If necessary, expected travels to Europe for audits.
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