Vacancy Sr Quality Assurance Officer – QMS – Oss


Organization

15 NOV ’21: For a Dutch Biotech organisation specialised in cellular immunotherapy, we are looking for a Senior Quality Assurance Officer QMS. This organisation focuses on the research, development, production, medical use of NK cell-based therapies and works with selected partners looking after patients, staff, and the environment.

Do you want to make an impact and represent the QA department in significant complex projects with respect to improvement and efficiency projects? Then this might be something for you!

Function

As a Senior Quality Assurance Officer QMS, you are responsible for establishing a quality system of allogeneic cell products in accordance with GMP and applicable international guidelines. You will fulfil a key role by contributing to improving the Quality System, implementing and improving current procedures and processes such as management training, audits and vendors. You will also maintain and evaluate quality indicators.

Other tasks and responsibilities:

  • You will lead multiple QA projects such as the implementation of a management system and an electronic quality management system
  • Work closely with other departments for training, change control, CAPA, deviation, risk assessments audit management, and documentation
  • Performing and reviewing internal and external audits, as lead auditor, to determine compliance with applicable guidelines (like GMP, GLP and GDP)
  • Be able to weigh the risk of the event and provide the most efficient compliant solution
  • Write, implement, review and maintain procedures and other QA-related documentation in alignment with applicable GxP guidelines
  • Identify documents that need to be created or updated and ensure this is organised

Requirements

The perfect candidate for this role should meet the following criteria:

  • BSc/MSc. in Science, Biotechnology or equivalent background with a focus on cell biology and/ or human cell culturing techniques (stem cells, primary cells, and/or tissue culture)
  • Five years’ experience in a GMP-environment with at least three years’ experience in Quality Assurance
  • Fluent in English
  • Eye for detail
  • High-level of independence
  • Prioritisation skills and a team player

Offer

The organisation can provide you with the following:

  • This is a unique opportunity to join a fast-growing organisation and you will become part of a group of committed and passionate professionals
  • Expected gross salary range of €58,000.- to €62,000.- depending on experience

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Sharon Lou
Associate | Biotech/Pharma division

+31 6 13 62 78 20
+31 23 754 86 60
s.lou@qtcrecruitment.com