Quality Engineer

What are your responsibilities?

  •  Responsible as technical reviewer/approver for lab equipment qualification, maintenance and retirement documentation, including calibration and testing protocols of external parties guaranteeing compliance quality policies. 
  • Provides technical expertise in investment projects for laboratory equipment, including selection of vendors and their products, and actively participates in the purchasing decision and process.
  • Acts as SME and participates in global projects for Data Integrity activities related to computerized and non-computerized lab equipment. 
  • Maintain the QCB qualification planning.
  • Responsible for providing technical expertise and performing review tasks related to MMD-GCM changes and ECM changes concerning lab equipment.
  • Responsible for establishing the annual maintenance program in collaboration with internal and external parties, providing the technical information for contractual terms as needed.
  • Participates in site and global quality improvement projects and acts as a point of contact and SME for lab equipment.
  • Responsible for initiating changes related to lab equipment. 
  • Supports lab investigations process as needed.
  • Acts as Person in Charge responsible for archive of equipment related documentation. 
  • Technical approval of  purchase and qualification documentation of laboratory equipment in line with current quality directives. 
  • Acts as quality expert for laboratory instrument maintenance and automation. 
  • Responsible for the archive of approved documentation 
  • Assures that documentation is drafted and reviewed/approved according to guidelines.

Who are we looking for?

  • HBO or Msc degree related to the Life Sciences field
  • Knowledge and experience with quality and compliance guidelines, cGMPs 
  • Knowledge of industry guidance and respective regulations of Equipment Qualification and Maintenance,  Validation, Quality Control, Quality (Management) Systems, Documentation, Change Controls
  • Technical knowledge in testing techniques and lab equipment
  • Technical Writing, Failure Mode & Effect Analysis (FMEA), and Lean Six Sigma.
  • Effective project management planning skills and ability to communicate on prioritization and bring others on the same page
  • Computer literacy knowledge
  • Ability to work under minimum supervision.
  • Strong focus on clients and end-user
  • Hands on mentality
  • Good communication skills and being pro-active and flexible
  • Team work oriented
  • Flawless Integrity Mindset (Data Integrity)
  • Excellent interpersonal and communication skills, oral and written (Dutch and English)
  • At least 5 years of relevant experience preferably in pharmaceutical Quality Control and cGMP. Furthermore, a sound knowledge of equipment design and use.

What does QbD offer you?

  • A young and dynamic company with a feel good culture, and a great openness and a no-nonsense approach
  • Real investment in people through education and fun events
  • A competence development model focused on your personal ambitions
  • An attractive salary package

Interested? Apply now by sending us your CV and motivation.