QA Gmp Associate

**Under the responsibility of the QA manager you are in charge of batch releases and Quality Assurances activities, for our Sophia Antipolis site in France.**

**RESPONSABILITIES**
- Perform the review of the batch records of the Pharmaceutical Establishment (manufactured internally or subcontracted)
- Upon official delegation from the Qualified person, perform the release of investigational pharmaceutical products and commercial products
- Accept raw materials, packaging and final products (IMP and commercial products) in the Nuvisan Manufacturing executive System
- Approve subcontracting/client contracts or TQA for GMP/GDP services
- Perform internal audits
- Perform qualification audits and periodic quality audits of suppliers and sub-contractors
- Write audit reports, recommend corrective actions as applicable and ensure appropriate follow-up
- Perform a peer-review of audits reports written by others
- Ensure worldwide regulatory and standard intelligence in the areas of quality and compliance
- Define GMP/GDP standards for quality training to ensure the implementation of quality strategy and policies
- Contribute to the readiness of the site for GMP inspection by Health Authorities and customer audits
- Provide Quality Management support and expertise to the Operations
- Contribute to the implementation and follow-up of quality management system
- Contribute to implementing and exploiting quality approach tools and audit results corrective actions
- Contribute to the update of Quality Assurance SOPs
- Contribute to collect data and prepare QA activity KPI (Key Performance Indicators)

**QUALIFICATIONS**
- Doctorate in Pharmacy
- Pharmacist registered in the section B of the CNOP (Conseil de l’Ordre des Pharmaciens)
- Knowledge of GMP
- Knowledge in biological products development (manufacturing, quality control ) and experience in sterile products would be highly appreciated
- You are autonomous, organized, rigorous, versatile and easily adaptable to a fastpaced environment with good communication and written skills.
- You have a sense of analysis, a developed spirit of synthesis. Your teamwork skills are recognized and you take initiatives
- Fluency in French and English, both written and spoken, is required.