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  • Location

    Leiden, Netherlands

  • Job title:

    QA Specialist

  • Sector:

    Biotechnology

  • Job ref:

    43529

The company
The mission of this company is to transform individual lives and fundamentally change the way diseases are interpreted, managed and in the end prevented. In over 150 countries the company is bringing innovative science and together with the most creative minds in the industry think differently about diseases. Trying to achieve the best possible results for their health.

For more than 25 years this company is a leader in the field of biomedicines. Within this department you will ensure the delivery of safe, cost effective and high-quality products for patients in need.

Role description
In the New Product Development group they provide end-to-end Quality support such as: CAPA, Change Control, Validation and Batch disposition for new biological products and vaccines. Used in Clinical Studies to prove their safety and efficacy.
As Quality Assurance Specialist you will be a core member in this team, representing QA in Engineering projects, support and assess and review the outcome of Quality Investigations.

Responsibilities

  • Represent Quality Assurance in Engineering projects
  • Provide Quality Assurance support to introduction and release of Raw Materials
  • Support technology and Analytical Transfer, improving existing manufacturing and analytical processes
  • Assess and review the outcome of Quality Investigations
  • Participate in Risk Assessments
  • Provide review and approval of document changes and change controls
  • Process improvement and Quality monitoring

Requirements

  • Minimum Bachelors’ degree or higher in a relevant field
  • Proven knowledge in the (bio-)pharmaceutical industry
  • 5 years’ of experience in a GMP regulated environment
  • Experience in methods such as: Process Excellence, Biologics, data analytics and proficiency in Lean or Six Sigma.

Are you the flexible candidate this company is looking for?
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