QA Specialist - QC Investigations & GMP Compliance
Company: Pauwels Consulting Agency
- Location: Ghent, Belgium
- Seniority: Entry level
- Employment type: Full-time
- Posted: 11 days ago
- Offer language: English
Job description
Our client, a leading biotechnology organization, is seeking a Quality Assurance Specialist to support manufacturing and QC operations. The role focuses on managing investigations and driving continuous improvement to ensure high-quality standards in the production of advanced therapies.
Responsibilities
- Review and complete routine non-conformance and deviation investigations within manufacturing and QC environments.
- Conduct interviews with laboratory personnel to provide quality insights for Trackwise investigation reports.
- Collaborate with stakeholders to implement effective CAPAs and ensure the timely completion of corrective actions.
- Propose and execute process improvements through the change management system.
- Monitor and report metrics on non-conformance investigations and quality performance.
- Maintain strict adherence to safety policies, quality systems, and cGMP requirements.
Requirements
- You bring experience in quality assurance, specifically focusing on deviations and non-conformances.
- You possess knowledge of QC laboratory environments and cGMP standards.
- You have experience with CAPA management and change control processes.
- You're proficient in quality management software such as Trackwise.
- You're proactive and solution-oriented with the ability to respond to urgent departmental needs.
- You are fluent in English.
Nice to Haves
- Knowledge of Dutch.
