Validation Specialist
Vor 4 Tagen
We are seeking a Validation Specialist for a dynamic and friendly working environment. This role is for an open-ended temporary contract. Fluency in French is required.
Your Responsibilities
- Generation and execution of qualification/validation protocols, including documentation.
- Collaboration with project teams to develop a validation strategy and statistically sound tests.
- Execution of test method validation and other qualifications to support product testing.
- Coordination of personnel for validation assignments.
- Development of statistically based sampling plans for in-process and final tests.
- Ensure compliance with cGMP, cGLP, QSR, and ISO requirements.
- Address comments and suggestions in validation and engineering documentation.
- Protocol, deviation, and summary report generation.
- Change control and non-conformance support.
Your Profile
- Bachelor's Degree in Engineering or Science.
- 2 to 5 years of experience in Validation or Quality Assurance for a medical device or pharmaceutical environment.
- Fluency in French and good English command.
- Excellent organizational and communication skills.
- Experience qualifying medical devices, equipment, or components.
- Excellent technical writing skills and good documentation practice.
- Competent in tracking and updating schedules.
- Microsoft Office tools and statistical techniques knowledge.
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