Qualification/Validation Manager F/M

Il y a 2 jours

Lyon, Auvergne-Rhône-Alpes, France Audensiel Temps plein 60 000 € - 90 000 € Contrat

Audensiel Healthcare, a young innovative company, was born from the desire to bring expertise and responsiveness to its customers in the Pharmaceutical, Biotechnology and Medical Devices sectors.

Our engineering and consulting firm, a human-sized company, has the mission to contribute to the improvement of the productivity of our customers, through complementary business expertise: Engineering and new works, Commissioning, Qualification/ Validation, Regulatory Affairs, Quality Assurance, Operational Excellence.

Proud of our values, we have been awarded the «Great Place to Work» label, synonymous with the well-being of our employees and our commitments to them.

As part of the development of our activities, Audensiel Healthcare is looking for a Qualification/Confirmed Validation Manager.

As an Audensiel Healthcare consultant, your missions will be to solve the problems of our main customers and to bring your know-how.

  • - Set up the qualification strategy (drafting the VP)
  • - Perform risk and criticality analyses, using the FMEA method
  • - Write and/or approve commissioning (FAT/SAT) and qualification protocols: IQ / OQ / QP
  • - Organize tests with cross-functional departments (production, maintenance, etc.) and supervise tests
  • - Write and/or approve commissioning and qualification reports: IQ / OQ / QP
  • - Manage non-compliance with Quality Assurance
  • - As part of TSF, travel to suppliers is expected and a level of technical English is required