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RESPONSABILITIES

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.

  • Perform the review of the batch records of the Pharmaceutical Establishment (manufactured internally or subcontracted)
  • Perform review of RQP’s of products manufactured by external CRO’s
  • Perform review of deviations and change controls related to products manufactured by CRO’s
  • 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
  • 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

  • Master degree specialized in Quality Assurance
  • Knowledge of GMP
  • Knowledge in biological products development (manufacturing, quality control ) and experience in sterile products.
  • 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

We are an equal opportunity employer and seek to hire the best candidate regardless of age, creed, disability, ethnicity, gender or sexual orientation.

Contact person

Rosanna Salomon Responsable Ressources Humaines