Quality Assurance Officer

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Job description

Responsibilities:

  • Assist the Head of QA France for coordination and oversight of the ISO 9001 Quality Management System according to applicable regulatory and legal requirements related to clinical research
  • Contribute to SOP writing/review and update SOPs and other quality system documents
  • Facilitate client audits, ensure follow-up of CAPAs for France
  • Conduct internal audits, quality controls
  • Assist in qualification and quality follow-up of partners/providers, audits
  • Participate in quality meetings, and quality annual review
  • Handle and follow-up non-conformities, corrective actions, preventive actions
  • Ensure risk management process according to applicable regulatory and legal requirements
  • Conduct relevant internal quality trainings
  • Reply to questionnaires from clients that are related to Excelya France
  • Participate in Computerized Systems Validation
  • Maintain ISO 9001, ISO 27001 certificates
  • Guide people in quality issues

 

Profile & Requirements:

  • You have a bachelor’s degree in life or health studies
  • You have a master’s degree in quality assurance
  • You have at least 3 years experience in a contract research organization or other pharmaceuti-cal Quality Assurance function, including experience with GxP Quality System development, support and maintenance
  • You have excellent written and oral communication and interpersonal skills
  • You are professionally fluent in English and French
  • You have excellent knowledge of Good Clinical Practices (GxP), ISO 9001 norm
  • You are able to collaborate cross-functionally

 

As part of our growing organization, you will have the opportunity to play an important role in the strong and unique development of Europe's first independent CRO!

You will play a role that can be shaped by your own actions and initiatives, in a company recognized for its personal touch and commitment. We have a culture of inclusion, where we share ideas and best practices and where teamwork is a key characteristic.

 

Full-time permanent position

The position can be remote from France or ideally based in Boulogne-Billancourt or Bordeaux.

Summary

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