QA Associate
Locatie
Diepenbeek
Job omschrijving

To support the development, maintenance and adherence to the Softhale Quality Management System (QMS) in Softhale.

Document Control:

  • Maintenance of controlled document standards, issue, and archive
  • Maintenance of SOP training system including auditing of Training Files 

Compliance Monitoring:

  • Maintenance and follow-up of CAPA and Change Control systems
  • Maintenance, compilation, and analysis of Quality metrics
  • Preparation of materials for Quality System Reviews

Supporting work in the following area:

  • Maintenance of company certifications (ISO 13485)
  • QA review of project documents and records as necessary
  • QA review of vendor company quality documents and records as necessary
  • Preparation and reporting of internal and external audits
  • Continuous Improvement (CI) of the documents and systems of the QMS
     
Profiel van de kandidaat
  • Degree in Pharmaceutical Life Sciences or related fields
  • Knowledge of local and international regulatory requirements
  • Background and experience of 2 - 5 years in QA
  • Experience in the pharmaceutical industry - in GCP, PV, GDP and GMP is a plus
  • You are fluent in Dutch and English, both written and spoken
  • Outlook 365 experience is a must,other Quality software is a plus
  • You are pro-active, love to solve problems, you like to be challenged, autonomous, out the box thinker
Werkomstandigheden
You will start in a fast growing innovative company. At this moment in time, they are at a critical point of the development. You will join their mission to further advance and broaden the development of their platform and to build and launch a new generation of highly effective inhalable medicines on a global scale. Beside a great opportunity, you will receive a competitive salary.
Contact

If you are interested in this position and would like to know more about it, please contact:

Nele Geusens, PhD, Recruitment Consultant
T: +32 497 57 08 94
E: geusens@themagroup.eu