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Sr. QA Specialist

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04 JUN '24: For our client, a highly innovative Contract Development & Manufacturing Organisation in the middle of Leiden's BioScience park we are currently looking for an experienced Sr. QA Specialist to take on the Quality Operations within the team. The organisation evolves around supporting their clients, by providing a state-of-the-art facility and expertise, with the progress they need to make developing their medicines.




Leiden - Netherlands

40 hours per week

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QTC logo icon About your role

This is how you will make the difference

The responsibilities encompass a wide range of tasks; act as lead in the maintenance of the quality system, including e.g. regulatory surveillance, preparation the quality management review, supplier management and lead in quality improvement projects; act as superuser of the eDMS system, including continuous improvement and access management; act as lead in audit and inspection management; act as an internal Quality consultant on applicable regulations and related topics and translate these into daily practice and improvement of the QMS by developing and providing applicable trainings; advise on design of computerised systems validations and process validations including; cleaning validation, sterilisation validation, media fills and decontamination processes of clean rooms; act as mentor to (junior) QA specialists.

QTC logo icon what's needed

What you bring

To qualify for this role, preferably, you bring along a MSc degree in a relevant field, such as Biotechnology (or alike). besides the following applies:
  • Min of 5-7 years of experience in biotech/pharma GMP environment;
  • Broad knowledge of and experience with EU/FDA GMP guidelines and inspections;
  • Skilled in Lean/Six Sigma practices;
  • Experience in Quality Operations is essential;
  • Good command of English language, both verbally as in writing.

QTC logo icon What we offer

What's in it for you

Besides the possibility to join an essential organisation and trusted partner for the Leiden BioScience park, this organisation offers a range of variety in job responsibilities. The benefits are:
  • Competitive base salary, tailored to experience;
  • Fixed 13th month;
  • 30 holidays;
  • Pension plan;
  • Reimbursed health insurance coverage;
  • Travel- & work-from-home allowance;
  • Personal/professional development possibilities. 

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