QC Engineer Specialist

QC Engineer Specialist

The Quality Control (QC) Engineer Specialist is responsible for ensuring the integrity, reliability and compliance of analytical instruments and computerized systems throughout their lifecycle within QC and production environments. This role drives the qualification, calibration, maintenance, and retirement of equipment in alignment with global regulatory standards (GMP, GDP, FDA, EMA, ICH) and data integrity principles. Acting as a project leader and subject matter expert, the position ensures timely installation, validation, and integration of new systems, while maintaining operational continuity through strategic planning of re-qualification and preventive maintenance activities. The QC Engineer Specialist plays a critical role in safeguarding product quality and patient safety by implementing robust validation processes, managing compliance risks and leading continuous improvement initiatives. Additionally, the role supports digit...