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  • Location

    Amsterdam, Netherlands

  • Job title:

    Associate Director, Qualified Person

  • Sector:

  • Job type:

    Permanent

  • Job ref:

    42934

The Company

My client, a pharmaceutical company based in Amsterdam, is specialised in the development of medicines for neurological and neurodegenerative diseases. 

Role Description

As Qualifed Person EU you will be responsible for the batch certfication within the European Market of medicinal products for human use. This position requires a combination of People Management skills and QP Certification, as the team has be devevoloped from 2 to 5 delegated QP's. 

Responsibilities

  • Innovate and build out the QMS for the CMO's and distribution location
  • Act as Qualfied person as per EU Directive 2001/83/EC,2017/1572
  • Review and Approve Product Quality Reviews (PQR/APR)
  • Manage a team of 2-5 delegated QP's
  • Host internal and external Quality Audits
  • Assure QMS for Manufacturing License is appropriate and maintained.

Requirements

  • MSc. Pharmacy or Industrial Pharmacy
  • Recognized by Regulatory Authority as QP (Article 49 of Directive 2001/83/EC)
  • Strong knowledge of Pharmaceutical manufacturing processes
  • Experience in hosting regulatory inspections by FDA, EMA and other authorities

Other information

Interested? Do not hesitate and reply to this vacancy right away!

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