Quality Specialist

  • What are your responsibilities?

  • In this role you act as a Qualified person, you are responsible for releasing finished drug product lots while ensuring compliance with the requirements of the marketing authorization and good manufacturing practices.
  • As a Specialist Plant QA, you provide guidance and direction to Production, Maintenance & Engineering and Quality staff regarding compliance with quality standards and procedures. 
  •  You partner daily with production and engineering staff to support, enable and improve the production process 
  •  You partner with production staff in performing risk analysis and the establishment of quality limits and requirements 
  • You own, review and approve production and plant QA related documents (e.g. SOPs, Forms, Training) 
  •  You review and approve deviations and CAPA, initiate and own as needed. 
  • You perform impact assessment as part of change controls impacting production or QA processes 
  • You review and approve production equipment maintenance work orders 
  •  You review and approve test protocols before use in production 
  • You perform GMP compliance checks in production 
  • You participate in internal audits and lead as appropriate 
  • Participate in regulatory inspections and partner audits 
  • You assist in development and delivery of GMP training for QA and production staff 
  • You lead and participate in Plant QA related projects/global QA initiatives as needed 
  • You lead and assist in various investigations as needed 
  • You assist in validation activities as needed including review and approval of validation documents
  • Who are we looking for?

  • Master’s in science in Pharmacy or equivalent 
  • Knowledgeable, skilled and eligible to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person). 
  • Thorough knowledge of the processes involved in clinical and commercial manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation 
  • Acquired practical experience in Good Manufacturing Practice (GMP) ideally in a Secondary Packaging manufacturing setting 
  • Fluent in English 
  • 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.