Emplois en direct

As a Senior CSV Expert, you will lead validation projects and provide expertise on compliance strategies. You will mentor junior team members and ensure high-quality execution of validation deliverables.

Key Responsibilities:

• Define validation approaches and ensure compliance with industry standards.
• Act as a subject matter expert on Manufacturing (PCS, SCADA, MES) and Laboratory (LIMS, ELN, CDS) systems.
• Lead risk assessments and mitigation strategies.
• Guide test execution and validation documentation review.
• Lead CAPA investigations and ensure regulatory compliance.
• Prepare and present validation strategies during audits and inspections.
• Mentor junior team members and provide technical guidance.

Requirements:

• Experience: 5+ years in CSV, IT compliance, or validation in a regulated industry.
• Advanced knowledge of GMP, GDP, GLP, and pharma regulations.
• Strong expertise in Manufacturing & Laboratory validation processes.
• Excellent leadership and stakeholder management skills.
• Fluent in English (French is a plus).

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