Qualification/Validation Manager F/M

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 our customers' productivity 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, which is 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.

You will support the project team to:

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