Ryoji TERMOZ

En résumé

Entreprises

• Novartis - Regulatory and Quality Compliance Officer

  RUEIL MALMAISON 2006 - maintenant Working in a Pharmaceutical manufacturing site, the description of my activities are:
  - Management of the site suppliers and contractors including the identification and certification of new suppliers/contractors, the follow-up through the performance review, set-up of quality agreement, single point of contact for quality related topics as complaints, oversight of the external audit program, certified auditor (raw materials, packaging elements, manufacturer, 3rd party laboratory)
  - Supervision of the change control system locally and globally in connection with global Regulatory Affairs and worldwide QA position. Ensure proper KPIs and reporting to control the activity.
  - Act as QA SPOC for drug product transfer and CMC review for new drug application
  - Experience in several Health Authorities inspections to successfully maintain the site manufacturing license (French, FDA)
  - Continuous improvement of the quality systems and processes. Working in close collaboration with local and global quality control, purchasing, supply chain, manufacturing, validation, MS&T, Reg. Affairs
  - Quality oversight of the Regulatory compliance activities: TSE/BSE risk free evaluation, residual solvents assessment, QP declaration

• Eli Lilly - Quality Assurance officer

  neuilly sur seine 2003 - 2006 Batch record review and release, handling of deviations, CAPAs and customer complaints, quality support for manufacturing activities, GMP training, Health Authorities inspection support

Formations

• Université Strasbourg 1 Louis Pasteur

  Strasbourg 1994 - 2000 Pharmacie Industriel

Réseau

• Amandine COULOT

• Bruno SICARD

• Carine SUTER

• Hélène GOUBET

• Jean Paul WILHELM

• Julie HABERKORN

• Laura KAVALA

• Mathilde DROMARD

• Sébastien FISSON

• Stephan EHRHART