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Sr. QA Specialist - Trainee QP

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20 SEP '23: For our client, an highly innovative Contract Development & Manufacturing Organisation in the middle of Leiden's BioScience park we are currently looking for an experienced QA Specialist with the right education to be eligible for QP training. The organisation evolves around supporting their clients 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, including serving as the primary liaison with clients to manage quality matters and managing quality agreements. Internally, the role involves leading QA colleagues in project teams, providing guidance on regulations, leading change control initiatives, and advising on various aspects, from raw material selection to process validations. Additionally, the role includes hosting client audits, external auditing of service providers and suppliers, maintaining auditing programs, and serving as the focal point for regulatory authorities. It also entails batch disposition and certification in compliance with EU/FDA directives and handling Product Quality Complaint investigations and product recalls.

QTC logo icon what's needed

What you bring

To qualify for this role you bring along a MSc degree in a relevant field, such as pharmacy (or alike), allowing you to be eligible as a Qualified Person by IGJ. 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;
  • 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;
  • End-year financial incentive;
  • 30 holidays;
  • Pension plan;
  • Travel allowance;
  • Personal/professional development possibilities. 

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