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SR QA Officer

Other
Amsterdam
English

Description:

Our client is a biopharmaceutical company based in Amsterdam, The Netherlands. They focus on the treatment of blood cancers and inherited blood disorders aiming to make bone marrow transplantations, a risky procedure that is often the last hope for patients, safer and more efficient. This means they have a passionate team that is dedicated to make a huge difference for patients. If you are up to the challenge and would like to be part of their team, they are currently looking for a Senior QA Officer.

  • Responsible for correct use of QA systems, SOP’s and Procedures.
  • Responsible for reviewing master documents and batch documentation.
  • Responsible for performing internal and external audits autonomously.
  • Perform batch and (QC) test record review, including approval.
  • Write, review and approve applicable controlled documentation, eg. batch records, (audit) reports, protocols and other cGxP QMS documentation
  • Performing initiation, review and assessment of deviations, change control requests, CAPA’s, OOS and other QMS input.
  • Back up for QA Manager.

Requirements:

  • B.Sc./ M.Sc. in Biotechnology, Chemistry or equivalent field.
  • Minimal 6 years of experience in a similar role in an international working environment and minimal 8 years of experience in pharmaceutical industry.
  • Minimal 2 years of experience in auditing pharmaceutical and laboratory organisations.
  • Experience in GMP production/ Quality Control.
  • Excellent understanding and knowledge of cGMP/ ICH guidelines for both EU and USA.
  • Understanding of state-of-the-art practice in the cell therapy field.
  • Experience with competent authority inspections
  • Good command of English and preferably German language, written and verbal.


Work Hours:

40 hours per week