Astraveus is a French startup developing innovative automated bio-manufacturing equipment designed to support the production of cell therapies in a closed system, in compliance with the Good Manufacturing Practices. This cutting-edge technology integrates software and advanced analytics. Our equipment is aimed at international markets, including the USA, Europe, and Asia.

Location: Kremlin Bicêtre

Main responsibilities:

1. Support to R&D Teams in monitoring product testing and documentation

   • Write test protocols in collaboration with the relevant teams.

   • Review and validate test reports, ensuring they meet quality requirements and standards.

2. Deviation Management

   • Review descriptions and impact assessments provided by the R&D teams.

   • Oversee investigations to identify the root causes of deviations.

   • Validate impact assessments and ensure the closure of deviations.

3. Corrective Actions Monitoring

   • Help identify and recommend CAPA to address quality issues.

   • Monitor the effectiveness of corrective actions and provide feedback for continuous improvement.

4. Microfluidic chip Quality Control Database Management

   • Ensure proper documentation and updating of the Chip QC tracking database, maintaining the data integrity and accuracy.

   • Actively participate in working groups dedicated to optimizing the chip manufacturing and quality control processes.

5. Participation in Quality Documentation

   • Contribute to the creation and maintenance of quality documentation as part of the implementation of the quality management system, ensuring documents are compliant with internal standards and external regulations.

• Education: Currently pursuing a QA degree in Pharmacy or Engineering with knowledge of quality management methodologies and root cause analysis

• Skills:

  • Ability to work independently while collaborating effectively with cross-functional teams

  • Excellent written and verbal communication skills

  • Attention to detail and a proactive approach to problem-solving.

• 1st interview with the Recruitment Team

• Fit interview with the Head of Quality Affairs and the Head of People