QA Complaints Associate

What are your responsibilities?

  • Complaints handling (including performing assessments) in accordance with internal procedures, regulatory guidelines and business performance objectives. 
  • Initiate and own product quality complaints, Safety quality investigations and product security investigations for commercial and/or clinical products 
  • Perform assessments in support of complaint investigations (e.g. batch record review, reserve sample inspection, Return sample inspection and Safety Features verification) 
  • Partner with corporate product quality surveillance, assessors from other sites and contracted partners to resolve product complaint investigations 
  • Partner with affiliates in country and intake call centers on call intake procedures and complaint investigations 
  • Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements 
  • Assist in Breda projects and improvement efforts as needed 
  • Provide training to affiliate staff on complaint handling procedures and performing investigations/assessments 
  • Initiate and own QA Non Conformances/CAPAs as needed 
  • Participate in site regulatory inspections of complaint handling process and in audits (internal and third party) as required. 

Who are we looking for?

  • Master's degree or Bachelor’s degree in Life Sciences 
  • Typically 3 or more years of related professional experience 
  • Fluent in English and Dutch language.  
  • Related professional experience  
  • Experience in Quality Assurance, including handling product complaints investigations 
  • Experience in pharmaceutical industry

What does QbD offer you

  • A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
  • Real investment in people through education and fun events
  • A competence development model focused on your personal ambitions
  • An attractive salary package

Interested? Apply now by sending us your CV and motivation.