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  • Location

    Utrecht, Netherlands

  • Job title:

    Quality Manager / QP

  • Sector:

    Pharmaceutical

  • Job type:

    Permanent

  • Job ref:

    44423

  • Startdate:

    2020-06-25

Quality Manager / QP

The Company

This company, located in the Amsterdam, is leading in the development medicines for immuno-oncology and rare diseases.

Role Description
As Qualifed Person EU you will be responsible for the batch certfication within the European Market of medicinal products clinical trials and commercial produts. This position requires a combination of Project Management and Quality Improvement

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
  • 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 (preferably ATMP's)
  • 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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