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Senior Quality Specialist

  • Job type: Permanent
  • Location: North Holland
  • Salary: Competitive
  • Job reference: 314223/002_1528887436
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 13/06/2018

Senior Quality Specialist

A global biotechnology company specialising in rare diseases and orphan drugs are giving the opportunity for a Senior Quality Specialist to join the team in Amsterdam. They operate in over 100 countries and their core therapeutic areas are Haematology, Immunology, Neuroscience and Oncology. The role will be in an external manufacturing facility to oversee the commercial, operations, and Quality functions are performed.

The Role

You will be responsible for the batch review and coordination or product release activities at the external manufacturing facility. You will play a key part in managing the Contract Manufacturing Organisation's (CMO) relationship and ensure batches are released on time.

Responsibilities:

  • Prepare and review batch release risk assessment

  • Be responsible for all batch releases and across Europe

  • Review/approve CMO provided documents

  • Maintain QMS database

  • Assist in the preparation of Annual Product Quality Reviews, complaint investigations, change controls

Requirements:

  • QA experience in pharma/biotech industry

  • Knowledge and understanding of GMP regulations

  • Experience working with Quality Management Systems

  • Fluent in the English Language, written and oral

Package:

  • Salary ranging between €50,000 - €60,000

  • KPI Bonus between 5-10%

Apply:

Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities please contact: Matthew Lancaster or phone +44203758831

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