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  • Location

    Hoofddorp

  • Job title:

    Quality Systems Specialist (Junior/Senior)

  • Sector:

    Biotechnology

  • Job ref:

    49789

  • Start Date:

    2022-11-21

The company

Our client is one of the leading players within the area of cancer treatment,. They are a pioneer in cell therapy research and consequently have a leading position in the immuno-oncology space.

The role

As a Quality Systems Specialist, you will be supporting the deployment or management, including training, of the client’s Quality Systems in a broad sense and you’ll be reporting to the Senior Management Quality Systems Manager.

Responsibilities

  • Ensure Quality Systems conformance to regulations and quality policies
  • Manage the Change Control system
  • Support regulatory inspections and audits
  • Ensure proper maintenance and approval of cGMP documents
  • Ensure proper maintenance of the client’s Exception Management system
  • Review and approve proposed changes to systems and procedures

Requirements

  • Bachelor’s degree in Chemistry/Microbiology/Engineering or similar
  • 5+ years of Quality Assurance experience
  • Strong knowledge of GMPs, pharmaceutical Law and legislation
  • Experience with Change Control, CAPA, Internal Audit, Deviations and other ICHQ10 quality systems
  • Strong knowledge of aseptic manufacturing processes.
  • • Proficiency in MS Word, Excel, Power Point and exception management systems

Other information

Do you think it can be your next step? Do not waste time and apply via the link: