Investigation & Client Quality Specialist

:



• Manage Deviations and Investigations related to quality issues of batches for clinical and commercial use.


• Coordinate the CAPA system stemming from quality investigations.


• Support the preparation of periodic quality trends for Management and Corporate dissemination.


• Actively participate in Operational Excellence initiatives and projects.


• Review and manage Deviations and Investigations with other company functions to determine root causes and implement corrective actions.


• Ensure the efficiency of corrective actions over time.


• Collaborate in coordinating technical and management meetings with clients.


• Participate in client visits, quality inspections, and regulatory audits.


Requirements:



• Proven experience in quality management and investigation processes.


• Strong collaboration skills to work with Compliance colleagues and support various functions.


• Ability to generate detailed reports related to quality events.


• Excellent communication skills to provide customer support and train personnel.


• Competence in preparing QA Ts and negotiating quality sections of contracts.


• Expertise in handling GMP batches and supporting Readiness and BU processes.

Make your mark with Thermo Fisher Scientific and join our mission to make the world healthier, cleaner, and safer!