Overview
Senior QA & QC Engineer (CAR-T) Jobs in Ghent, Flemish Region, Belgium at Pauwels Consulting
Title: Senior QA & QC Engineer (CAR-T)
Company: Pauwels Consulting
Location: Ghent, Flemish Region, Belgium
Our client, a leading biotechnology organization, is seeking an experienced professional to manage quality investigations and process improvements. This role is responsible for driving excellence in compliance and manufacturing within a highly regulated environment.
Responsibilities
- Review and complete manufacturing and QC non-conformance and deviation investigations.
- Collaborate with stakeholders to implement effective CAPA and ensure timely completion of corrective and preventive actions.
- Provide recommendations for process improvements by working cross-functionally across the organization.
- Execute improvements through the change management system in close collaboration with management.
- Report and monitor quality metrics on investigations and corrective and preventive actions.
- Ensure all tasks are performed in accordance with cGMP requirements and safety policies.
Requirements
- You have 8+ years of relevant experience in a pharmaceutical or biotech quality environment.
- You bring expertise in CAPA lifecycle management, deviation management, and non-conformance investigations.
- You possess a strong background in GMP compliance monitoring and change control processes.
- You have experience using quality systems such as LIMS and investigation reporting tools.
- You’re known for your advanced time management skills and ability to respond with urgency to cross-functional needs.
- You are fluent in English.
Nice to Haves
- Experience specific to CAR-T manufacturing or advanced therapies.
- Active knowledge of Dutch.
