Jobs

QA Engineer

Discipline
Location
Antwerpen
Vacancy ID
72057

Responsibilities

  • As a QA Engineer you review batch abstracts to release products in accordance with approved specifications and procedures.
  • You monitor partner compliance through GxP documentation reviews and on-site visits.
  • You distribute relevant documentation for Regulatory, Validation, and Subject Matter Expert review.
  • You collaborate with multi-functional internal and external project teams to ensure compliance.
  • You address technical and quality issues and resolve scheduling and process-related conflicts. 
  • You demonstrate an understanding of regulations related to the manufacturing of medicinal products (biologics).
  • You manage notification flows within quality systems between internal and external partners.
  • You monitor contractor performance to establish Key Performance Indicators (KPI's) and to report adverse trends. 
  • Depending on experience, there is an opportunity to work abroad.  

Requirements

  • Master’s degree and 3-5 years of experience in a cGxP or other regulated environment are required, with at least 3 years in a quality role. Experience in an international role is a plus.
  • Excellent communication and organizational skills are essential.
  • Proven ability to perform work with attention to detail and ensure high quality (i.e., right the first time).
  • Fluency in spoken and written English is necessary. Dutch is a plus.
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