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R&D QA Engineer Biopharma Budapest

Carbyne
On-site
Budapest, Hungary
QA Engineer
Our client is a European biopharma that develops, manufactures and commercializes biological substances. Due to the expansion of the production site in Hungary, we are looking for a QA Engineer to join their team of 3 people. The purpose of the newly formed position is to bring GMP approach to the laboratory and improve the GLP/GMP relay.

As a QA Engineer, you will play crucial role in supporting growth, by:
  • ​​​​​​​Supporting, maintaining and improving the quality system related to the production
  • Ensuring that the method validation, stability and transfer studies are conducted in accordance with applicable regulations and quality standards
  • Reviewing SOPs to Industrial Development in accordance with GMP and internal standards and releasing documentationΒ of R&D related to production activities
  • Review the batch records and release development products for Industrial development studies
  • Participation in investigations related to development products, as requested
  • Participation in trend analysis of investigation of deviations and complaints related to development products, as requested
  • SupportΒ internal/external audits and execute requested CAPAs
Requirements to fill the position: ​​
  • MSc in Life Science related topic (pharmacy, biology, biotechnology, etc.)
  • 3-5 years relevant professional experience in quality assurance (GMP)
  • Excellent knowledge in MS office applications
  • Fluent in English (both oral and writing)

​​​​​​​Should you be interested in the details of this vacancy feel free to leave a comment with your details or submit your CV for this role.