Senior QA

Il y a 7 jours

East Flanders, Flanders, Belgique Pauwels Consulting Temps plein

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.