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CSV Coordinator at Chemours - ApplyBlast

CSV Coordinator

Chemours

3 months ago

3.5 on Glassdoor

Madrid

Onsite

Full Time

Senior

0 applicants

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About this role

Algenex seeks a CSV Coordinator with 5-10 years of experience to lead Computer System Validation activities at its biotherapeutics facility in Tres Cantos, Madrid. The role involves overseeing the lifecycle validation of computerized systems to ensure regulatory compliance, data integrity, and quality standards within a highly regulated pharmaceutical environment.

Responsibilities

Coordinate and supervise computerized system validation activities across the entire plant
Define and execute a risk-based validation strategy for new and existing systems
Ensure compliance with CSV regulations, GxP guidelines, and data integrity principles
Manage external vendors and consultants involved in validation processes
Lead the preparation, review, and approval of comprehensive validation documentation