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  • Location

    Leiden, Netherlands

  • Job title:

    GMP and Documentation Specialist

  • Sector:

    Biotechnology

  • Job ref:

    44829

  • Startdate:

    2020-09-01

The Company 
Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden.The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.

This department has a GMP manufacturing facility where they produce medicines against diseases such as vaccines against HIV, RSV and Ebola.

Role Description 
As a GMP and Documentation Specialist you will be the first point of contact within the production teams for questions related to cGMP. Such as: training, inspections, audits and documentation. 

You will work on the maintenance and improvement of the cGMP systems. Bringing a detailed understanding of cGMP and GMP documentation systems. With expertise in handling non-conformances and follow-up.

Responsibilities 

  • First point of contact for questions about cGMP systems
  • Initiating and handling of compliance records such as: Change Control, nonconformances and CAPA records, including root cause analysis
  • Support and lead in keeping process documentation up-to-date
  • Coordinate the training systems within the department

Requirements

  • Bachelor of Science with 3 years' of (Bio-)Pharmaceutical experience
  • Experience with change controls, non-conformances and CAPA records
  • Experience with cGMP and EHSS standards
  • Lean certification is preferred

Other Information 
Are you the accurate, initiative and independent candidate that this company is looking for? Apply via the button below!

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