Qualification/Validation Manager F/M

Audensiel; Lyon; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Audensiel Healthcare, a young innovative company, seeks a Qualification/Confirmed Validation Manager in Lyon to define qualification strategy and oversee risk analyses and test execution.

You will draft and approve IQ/OQ/QP protocols, coordinate cross-functional tests, supervise FAT/SAT activities, and manage QA non-conformities. Travel to suppliers and strong technical English are required.

Qualifications

• Must have experience drafting qualification strategy (VP).
• Perform risk and criticality analyses using FMEA.
• Write/approve IQ/OQ/QP commissioning and qualification protocols.
• Organize tests with cross-functional departments and supervise tests.
• Write/approve commissioning and qualification reports.
• Manage non-conformances with Quality Assurance.
• Travel to suppliers as part of TSF; technical English required.

Responsabilités

• Set up the qualification strategy (draft VP) and oversee validation activities.
• Conduct risk analyses and criticality assessments (FMEA) across projects.
• Authorize and validate IQ/OQ/QP protocols and FAT/SAT testing.
• Coordinate cross-functional tests with production, maintenance, and QA.

Description du poste

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