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Qualified Person (QP)

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For a worldwide leading manufacturer and supplier in the pharmaceutical industry, we are looking for a Qualified Person (QP). The organisation has been in existence for over eight decades and has extended their presence to 80 countries worldwide, providing over 1500 pharmaceutical products across diverse therapeutic categories. They strive for high quality and affordable medicine to support patients in need. You will be working in a multicultural team and you report to the Head – QP (EU).

Details
  • Pharmaceutical
  • Quality/RA
  • Bilthoven
  • 40 hours p/week
Get to know

Our subject matter

About your role

This is how you will make the difference

In this position you are responsible for all QP related matters and you are partly involved in QA activities. You make sure that all imported products meet the guidelines before you release them and you make sure that the QMS is kept up-to-date and improved as well.

Activities

  • Ensure full quantitative and qualitative analysis of products imported from outside the EU
  • You ensure that the necessary release certificates are completed and issued in accordance with EU guidelines
  • Ensuring that the required amount of reference samples is stored for each batch of products released and distributed
  • Provide certifications for product release or sale on the EU market
  • Maintaining quality management reviews, annual product reports, change controls, self-inspections, CAPAs, deviations, etc
  • The necessary quality agreements have been made with third parties who carry out GMP related activities
  • Keeping up-to-date and improving the overall quality system in accordance with the company’s regulations and legal framework
  • Planning, directing and monitoring all employees involved for the necessary guidelines/SOP training courses
  • Validate and improve production and quality processes

Requirements
The ideal candidate for this position has:

  • 3 – 5 years of demonstrable work experience as a Qualified Person (QP) with a QA background
  • Certified, trained and familiar with EU medicines regulations
  • Knowledge of EU legislation and regulations and GMP
  • Excellent command of the English language verbally and in writing
  • Experience working in a larger pharmaceutical organisation is a plus
  • You have the power to say yes/no to regulatory authorities and corporate management
  • You can act ethically to make the right decisions

What we offer

What's in it for you

The basis for your employment conditions is based on your work experience and knowledge.

  • Salary indication approx. €75,000.- – €85,000.- based on experience
  • Career and training opportunities
  • Good secondary employment conditions package
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