Qualification & Validation Strategy Lead

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, 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.