Qualification/Validation Manager F/M
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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