Compliance Specialist

What are your responsibilities?

  • Maintain the supply Chain Distribution manual 
  • Participate in Supply Chain Distribution Risk Management activities 
  • Own and manage temperature assessment records (CTETS) 
  • Own and manage class 1 and class 2 non-conformance records and lead root cause analysis sessions 
  • Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended. 
  • Manage missing product notifications, including leading Event Review Team meetings if applicable. 
  • Author and Own documents (procedures, forms, manuals, training materials, etc) for the Customer Success department and the Compliance team. 
  • Support audits and inspections involving EU supply chain, including audits and inspections at the affiliate level. 
  • Support activities for product recall or annual mock recall exercises. 
  • Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis 
  • Incidental travel might be required

Who are we looking for?

  • Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance 
  • In the absence of a Life Sciences degree, 7+ years’ experience in GMP / GDP compliance 
  • Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice. 
  • Fluency in English and Dutch (preferable) 
  • Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. Trackwise, EDMQ, etc) 
  • Experience in audit / inspection support 
  • Technical writing skills 
  • Effective communication skills at multiple levels, areas and countries 
  • Ability to apply risk-based approach, making decisions and escalating issues appropriately 
  • Analytical and evidence-based approach to problems. 
  • Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together. 
  • Pro-active in proposing solutions and driving tasks to completion 
  • Works autonomously, respecting deadlines 
  • Works with a high degree of discipline and attention to detail

 

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.