QC – method validation professional

What are your responsibilities?

You will be responsible for (analytical) method validation process validation to ensure compliance with regulatory expectations and consistency with current industry practice.
  • Monitor and assess new developments, industry trends, evolving regulatory expectations in the analytical method validation field
  • Support QC analytical method validation improvement programs
  • Establish and maintain current knowledge of global regulations, regulatory expectations, inspection intelligence and industry standards
  • Ensure compliance with external and internal requirements
  • Define the product requirements and contribute to the development of policies and standards
  • Work with a network of local experts and ensure sharing of best-practice and learnings
  • Monitor and analyse assessment criteria on the system performance (incl. trend analysis, effectiveness evaluation

Who are we looking for?

  • You possess a master degree in Sciences: chemistry, microbiology, biological sciences, pharmaceutical science, bio- or chemical engineering or related field
  • You have at least 4 years of experience in Biologicals or Pharmaceutical Industry and have proven experience within (analytical) method validation
  • You are familiar with GMP/GLP and international regulations and guidelines
  • You are familiar with analytical techniques like HPLC, PCR, GC, …
  • You have an analytical mind and are able to translate complex processes into clear, efficient and compliant procedures 
  • You have a good knowledge of quality and risk management principles and tools
  • You are an excellent communicator in Dutch and English (spoken and written)
  • You organise your work efficiently and know how to deal with pressure and deadlines
  • You possess good IT-skills (eg Outlook, Word, Excel, Powerpoint,…)

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.