Quality Assurance Representative / Qualified Person
Dyax Corp.
Vienna, Wien, AT
vor 8 Tg.
functions :
  • if qualified >
  • if qualified >
  • release and certification of lots as Qualified Person acc. to EU GMP Annex 16 and AMBO 2009

  • preparation of necessary documentation to release Finished Goods lots
  • lot release of Finished Goods lots in IT systems (SQL*LIMS and C3ME) after QP certification
  • issue customer / country specific documentation / protocols (CoA) in English
  • reply to customers’ requests (mostly in English)
  • maintenance of CoA templates
  • coordination of in time lot release and issuing of documents
  • support and follow internal and external compliance
  • other administrative tasks
  • requirements :

  • science education (e.g. pharmacy, chemistry, biology) : FH or university; accredited Qualified Person beneficially
  • experience in pharmaceutical industry (in a quality function beneficially)
  • experience of working under GMP requirements desirable
  • knowledge of IT systems required (e.g. Office 365, SQL*LIMS, C3ME, SAP)
  • very good skills in German and English spoken and written
  • independent and accurate working; flexibility and ability to cope with stress
  • ability to work in a team; very good communication skills
  • As a leading global biotechnology company we have one mission every day : to lastingly improve the lives of people living with rare diseases.

    Crucial to our mission are our employees our biggest asset who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-

    life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.

    We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps.

    Diversity is part of our success! The minimum salary for this position is € 3.163,33 gross per month (full-time); increased payment is possible.

    We are looking forward to your application.

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