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QA Specialist

We are looking for an enthusiastic QA Specialist with a strong sense of urgency and a passionate to getting things done. We are currently looking for a QA Specialist with strong knowledge of both cGMP guidelines and Quality Management systems.

Job description

As a QA Specialist you will work in close collaboration with other departments (Operations, Lab, Engineering, Vaccines Launch Facility and Development Departments). You will provides end-to-end Quality support

  • non-conformance management,
  • CAPA,
  • change controls
  • validation and batch disposition for new biological products / vaccines.

Responsibilities

  • Participate as Core Team Member in New Product Introduction projects
    * Represent QA in Engineering projects related to the manufacture of Biological /Vaccine products OR
    * Provide QA support to the introduction and release of (new) Raw Materials
    * Provide QA support technology and/or Analytical Transfer and improvement of existing manufacturing / analytical processes
    * Assess and review the outcome of Quality Investigations, provide support as part of the investigation teams and monitor the quality of the Root Cause investigations
    * Provide Quality support for the development of appropriate Corrective and Preventative actions
    * Participate in risk assessments to ensure compliance or quality is not jeopardized
    * Is involved in initiatives that lead to a higher quality and compliance culture throughout the organization, including GEMBA walks in manufacturing areas and the laboratory
    * Provide review and approval of document changes and change controls
    * Lead or act as member for local or global capacity/quality projects
    * Optimize current and identify new ways of process and quality monitoringSupport in

Profile

  • BSc or MSc in the fields Biochemistry, Life Science or similar (Phd or MBA is considered overqualified for this position
  • Proven knowledge of the biotechnological/pharmaceutical industry
  • At least 5 years of experience in a GMP regulated environment (not necessarily QA)
  • General knowledge of vaccines is considered a great plus
  • Excellent analytical abilities, eye for details.
  • Excellent communication skills, and a team player attitude
  • Experience in data analytics and data visualizationYou have an excellent proficiency in English both in word and in writing. Dutch is a pre.

Terms of employment

  • Employment: temporary contract with prospect of a permanent contract
  • Salary indication: from € 3500 to € 5000
  • Working hours: 40 hours per week (part-time can be discussed)
  • Location: Leiden region

Vacancy number: 15765