Vacancy QA Officer – Herstal


Organization

The organisation is a contract development and manufacturing organisation specialised in the production of biologics (recombinant proteins, antibody fragments and plasmid DNA) for therapeutic, vaccine and diagnostic applications. The services proposed include the development of the manufacturing process and the production of purified material for realisation of preclinical and clinical studies. Due to growth of the company, they are looking for Quality Assurance now.

Function

In this position you are responsible for setting up a QMS according to the GMP standard. You are also involved in monitoring and improving the overall quality and drawing up qualification protocols. You work together with your colleagues in the QA department and you report to the QA team leader.

Activities:

  • Setting up and maintaining the QMS according to the GMP guidelines (drafting, reviewing and implementing various procedures and documents, archiving management)
  • Approving, releasing and reviewing raw materials
  • Support in supplier qualification
  • Review and approve production documents and analytical batches
  • Drafting validation, qualification protocols, approving validation and qualification papers
  • Follow up and monitor the qualified status of cleanrooms
  • Conducting risk analyses, managing change, implementing and monitoring CAPA plans
  • Conducting internal audits and active participation in external audits by clients and regulatory authorities

Requirements

You are the ideal candidate if you meet the following requirements:

  • Completed bachelor’s degree in life science
  • 1-3 years work experience in a QA position
  • In-depth knowledge of GMP regulations
  • Excellent command of the English and French language

Offer

They can offer you the following

  • Permanent contract
  • Salary package including various benefits

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Romy Snijder
Associate | Biotech/Pharma division

+31 6 58 81 46 32
+31 23 754 86 60
r.snijder@qtcrecruitment.com