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  • Location

    Amsterdam, Netherlands

  • Job title:

    Qualified Person

  • Sector:

  • Job type:

    Permanent

  • Job ref:

    43597

Qualified Person

The company
Our client is a pioneer in neuroscience

Role description
As QP you’re main responsibility will be the certification of Finished Goods within the EU of medicinal products

responsibilities:
  • You will do the certification for all products
  • You make sure that that each finished medicinal product batch has been manufactured in accordance with GMP, MIA and the MA.
  • You make sure that the QA answers the national and international regulations.
  • You will review and approve PQR/APR
  • You will ensure that at least one deputy QP is in place to perform EU QP Certification
  • You will participate in Quality Management Reviews
  • You will assure QMS for the Manufacturing License is appropriate and maintained.
  • You host GMP Health Authority Inspections
  • You host  internal Audits
  • You manager a team of 6 delegate QP.
Requirements
  • MSc in Industrial Pharmaceutical Science
  • Third level qualification in a science discipline
  • 8 years experience in the healthcare/pharmaceutical industry gained in a FDA and EMA approved pharmaceutical environment.
  • Experience as a QP from biotech or pharmaceutical industry.
  • Proven knowledge of AMG 2017

If you are interested in this role, please contact me at e.wienen@sire-search.com or at +31 20 658 98 00.
 

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