Quality Assurance Manager (ATX24-08)

Missions

• Development, maintenance and continuous improvement of the company’s quality system.
  – Drafting and/or checking procedures and other QMS documents.
  – Distribution of created/revised QMS documents to relevant employees, and management of associated awareness and training actions.
  – Initial QMS training for new employees.
  – Coordination and follow-up of periodic reviews of QMS documents.
  – Centralizing and processing requests for continuous improvement, non-conformities and complaints.
  – Updating and monitoring the implementation of the corrective and preventive action plan (CAPA) in collaboration with the operational teams and third parties.
  – Updating of the annual QMS action plan and regular reporting on progress.
  – Participation in the preparation of quality management reviews.
• Quality controls and internal process audits to improve the performance of the company’s activities.
  – Participation in the implementation of the internal audit/quality control plan.
  – Planning, execution and follow-up of internal quality audits/controls for the company’s key processes.
  – Support for the implementation of action plans resulting from external audits (audits of the company’s subcontractors).
• Standards and regulations watch
  – Monitoring of changes in standards applicable to the company.
  – Analyze standards and assess their impact on company’s processes/activities.
  – Informing and training teams on changes in standards and regulations.

Technical skills

• Solid knowledge of quality assurance standards (e.g. ISO 9001) and GxP regulations applicable to drug development in an international environment (e.g. GCP, GMP, GLP, GCLP).
• In-depth knowledge of R&D processes (preclinical and clinical stages prior to drug registration) and the players involved.
• Good document management practices.
• Proficiency in audit techniques.

Personal skills

• Fluency in English is essential, French would be a major asset.
• Planning, anticipation and organizational skills.
• Observation and listening skills, and excellent communication skills.
• Excellent writing skills.
• Thoroughness and precision.
• Ability to analyze, synthesize and solve problems proactively.
• Ability to be accountable.
• Ability to work both independently and cross-functionally (project mode) in a constantly changing work environment.

Professional experience

• Training in pharmacy, engineering or higher science (Bac +5), supplemented by training in quality assurance.
• Junior-level position; 1 to 3 years’ experience in managing a quality documentation system in the pharmaceutical R&D sector would be a plus.

To apply, please send your CV and cover letter application to jobs@aurobac-tx.com mentioning the reference ATX24-08.

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2024.10.17 ATX24-08 Quality Assurance Manager Job Ad