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QMS Specialist - Noord-Brabant

Organization

Our client is a global leader in the pharmaceutical market and active within a diverse set of therapeutic area’s. They have several locations within the Netherlands, but the position will be based in Noord-Brabant. As a Senior QMS Specialist, you will work within the quality department and make sure that the quality systems are in place to support all the operational departments.

Function

As Senior Quality Systems Specialist, you will actively contribute to continuous improvement of the QMS systems and the compliance plans. Intensive international contact will be a big part of the job, as well as collaborating with the internal departments on the quality systems. Your responsibilities will exist of but will not be limited to:

  • Quality council activities like internal and external auditing, contracts and agreements, managing the quality systems, providing GMP training and QMS training
  • Responsible for quality risk assessments and QMS improvements
  • Maintaining contact and relationships with internal and global players like the EMEA and the FDA
  • Preparing, executing and following up on all inspections and all relevant documents
  • Active contribution to supplier management and agreements


Requirements

  • 5-7 years of relevant experience in the pharmaceutical or biotechnology industry and cGMP
  • Excellent knowledge of relevant quality and compliance guidelines
  • Extended knowledge of quality risk management and tools
  • Experience with multiple document and quality management systems such as Sparta Systems (trackwise®) and SAP
  • Effective planning skills and strong focus on clients and end-users
  • Ability to convert quality mindset into practice and able to extend this knowledge to others
  • Interpersonal and communication skills (oral and written) in Dutch and English

Application

Joanna Hessels
Senior Associate Biotechnology

+31 (0)23 754 8660
+31(0)6 36 54 93 09
j.hessels@qtcrecruitment.com

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