Quality Assurance Specialist

7 days ago

Budaörs, Pest, Hungary Carbyne Full time 30,000 - 60,000 per year
Due to successful expansion, our USA-based Global Big Pharma partner is looking for an additional team member to fill the role of Quality Assurance Specialist / Responsible Person in Hungary. This is a great opportunity to deepen your professional knowledge on pharmaceutical product release for the local and other EU markets.

Your tasks:
  • Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products
  • Coordinate the Quality Management Review process at the affiliate
  • Represent affiliate QA in regional, global and cross functional teams, projects and programs, as assigned by management
  • Coordinate the Quality Management Review process at the affiliate
  • Ensure that a QMS is implemented and maintained (all GDP related activities are clearly defined and systematically reviewed; responsibilities processes and risk management principles in relation to distribution activities are clearly specified; the quality system is fully documented, and its effectiveness is monitored)
  • Ensure inspection of incoming goods and release to local market
  • Releasing products for local and other EU markets
  • As a responsible person, the post-holder has the right to make decisions in terms of responsibilities laid down in Decree No. 53/2004. (VI.2.) of the Ministry of Health, Social and Family Affairs on the wholesale and parallel import of medicinal products
You qualifications:
  • ​​​​​​​University Degree in Pharmacy
  • At least 1 year of practical experience in quality assurance of pharmaceuticals and pharmaceutical ingredients at one or more companies authorized for pharmaceutical wholesale
  • Comprehensive knowledge of national and EU GDP legislation
  • Proficiency in English
  • Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively
​​​​​​​Should you be interested in this position please let us know by submitting your CV via the advertisement - our collegues will soon contact you with the details.

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