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Manufacturing Systems Quality Engineer

il y a 2 semaines

Brainel'Alleud, Wallonie, Belgique TN Belgium Temps plein

About the Company

TN Belgium is seeking a skilled professional to join our team as a Manufacturing Systems Quality Partner. As a member of the Internal Bio & GT Manufacturing Systems Quality Team, you will play a critical role in ensuring the quality of our products.

The ideal candidate will have a strong background in quality assurance, a good understanding of regulatory requirements, and excellent communication skills. You will work closely with Clinical Manufacturing Teams to ensure that the Quality Management System supports product development and clinical supplies.

Your Key Responsibilities

  • Work closely with Clinical Manufacturing Teams to ensure quality support
  • Provide quality support for qualification and validation activities
  • Drive the continuous QA improvement process
  • Plan and manage compliance tours and on-the-floor spot-checks
  • Be a partner with other departments to identify, mitigate, and resolve compliance and quality issues
  • Support Change Control and perform QA evaluation
  • Ensure KPIs are adequately maintained and shared

Requirements

  • Masters degree in Sciences
  • Fluency in French and English
  • Good understanding of current regulatory requirements and expectations
  • QA/compliance experience in DS manufacturing, facility operation, laboratory compliance, and quality systems
  • Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects
  • Ability to work autonomously and handle complex/difficult situations