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Qualified Person (QP) EU - Amsterdam

  • Location

    Amsterdam, North Holland

  • Sector:

    Regulatory Affairs

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    23162_1616158895

  • Published:

    25 days ago

  • Consultant:

    Matt Thomas

Job title: Qualified Person (QP) EU - Amsterdam

A global vaccines pharmaceutical company is seeking a QP for their recently opened European Centre of Excellence for R&D and Quality. This role will be responsible for QA batch release at this site.

Responsibilities:

  • Perform QP release of products to market in compliance with the applicable licenses and legislated requirements for both Commercial and Clinical Trials.
  • Provide oversight of Pharmacovigilance follow up or recall required in response to Adverse Events and Product Technical Complaint investigations and trends
  • Input into the quality objectives and KPI's for the Batch Release and QA function and ensure these objectives are met
  • Host regulatory inspections and self-inspections
  • To provide QA/QP oversight of the testing and release functions and contribute effectively towards the strategic development of site systems.

Requirements:

  • EU Qualified Person
  • Vaccines, steriles and biological experience is preferable.
  • Substantial industry experience within a similar pharmaceutical/biotechnology business
  • A good track record with the MHRA, EMEA and other regulatory agencies.

Salary and benefits:

A highly competitive salary, annual bonus, car allowance and further benefits package is on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk