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Quality Systems Specialist - GMP

  • Locatie:

    Hoofddorp, Nederland

  • Contactpersoon:

    Maaike Wagenaar

  • Contractsoorten:

    Temp to Perm

  • Telefoon contactpersoon:

    +31 (0)20 406 97 50

  • Bedrijfssectoren:

    Pharmaceutical

  • E-mail contactpersoon:

    maaike_wagenaar@oxfordcorp.com

We are looking for an experienced Quality Assurance Professional to keep a helicopter view of the Quality Management System to ensure smooth production of cell therapy. You oversee a range of different processes and work with several different teams. Apply now if you have experience with overseeing a QMS!

Job description

You have a broad role in the quality team and are a compliance partner for many different departments within this production location. You look at the different aspects of the Quality System and ensure procedures are being followed correctly and timely. You specifically own procedures that involve many different departments within the site, such as Change Controls, Deviations, CAPAs, and internal audits. You check if procedures are followed properly, if suitable training has been provided, and identify quality risks in the entire site. Where needed, you will support with training. You have no direct reports and do not allocate tasks to people but you do track if work is being done correctly and on-time. You also follow-up with departments, take minutes in meetings and help with report writing. You have a dynamic role in Quality with rapidly-changing priorities, requiring some flexibility.

Responsibilities

  • Acting as a partner within quality for many different departments
  • Owning and maintaining inter-departmental parts of the Quality System
  • Ensuring procedures are followed correctly and timely
  • Provide support for trainings
  • Chasing departments for progress
  • Take minutes in meetings, help write reports


Profile

  • At least 5 years of experience within QA and with GMP
  • Experience with inter-departmental procedures and Quality Systems
  • Experience within aseptic manufacturing is a big plus
  • Able to quickly change priorities


Practical information and Benefits

  • Role until end of 2025 - extension is realistic
  • At least three days on-site required
  • Salary range: €60-70.000,- annually
  • Location: Hoofddorp
  • Vacaturenummer: 25794