For one of our prestigious clients in medical devices, we are looking for a QC Equipment Qualification Specialist available ASAP.

Main missions:

1. Manage qualification activities throughout the lifecycle (URS, impact analysis, FAT/SAT, IQ/OQ/PQ, commissioning and requalification).
2. Write, execute and approve qualification and validation documentation: protocols, reports, risk analyses, change controls, deviations and qualification plans.
3. Ensure the maintenance of the qualified status of laboratory equipment
4. Support installation, transfer or equipment upgrade projects, ensuring compliance with regulatory, quality and operational requirements.

Desired profile:

• Minimum 5 years of experience in laboratory equipment qualification.
• Proven experience in IQ / OQ / PQ qualification
• Good knowledge of GMP, deviation management, change control and risk analysis
• Experience in CSV (Computerized System Validation) is appreciated
• Field profile, autonomous, with good writing skills and multi-stakeholder coordination abilities.