Quality Regulatory Technician
il y a 1 semaine
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
**Job Purpose **(State the overall objective of the job)
Assist the Technical Director in the management and development missions of the affiliate quality system in accordance with French regulations for Medicines and IVD, GDP, ISO 9001 standards and internal procedures and corporate objectives.
Assist the Technical Director in drafting and updating regulatory documents.
**Major Accountabilities** (List main duties of the job and physical requirement if any)
The specific responsibilities include but are not limited to:
- Manage the quality documentary system
- Manage complaint and deviation handling procedure and corrective and preventive actions
- Manage Risk RA handling procedure
- Ensure the follow up of the change controls
- Ensures the follow ups of the KPIs
- Participates in the drafting and updating of the documents necessary as well as the Quality Manual
- Ensure the update and the follow up of the regulatory documents according to marketing authorization updates (packaging, mentions legalese, non-promotion/promotion materials,..)
- Provides support to process pilots and ensures the cohesion of processes
- Organizes and follow internal and external audits
- Perform Regulatory watch
- Assistant Preparation of meetings (Comité Qualité Produits, Comité de Bon usage, Quality Review)
**Location: Paris**
Learn more about Grifols
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