Senior Quality Assurance Specialist

4 weken geleden

Amsterdam, Noord-Holland, Nederland Kyowa Kirin Voltijd

Job Summary

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Kyowa Kirin. The successful candidate will be responsible for ensuring the quality of our medicinal products distributed in the EMEA region.

Key Responsibilities

  • Ensure compliance with GDP/GDP-API & GMP requirements for the distribution of medicinal products.
  • Implement and maintain Quality Management Systems (QMS) for medicinal product distribution activities.
  • Execute supplier and customer verification management, including onboarding, offboarding, and contractor risk assessment.
  • Monitor the quality performance of distribution contractors and propose actions for improvement.
  • Drive continuous improvement activities to support compliance with established licenses.
  • Ensure prompt and professional communication of key issues to senior management.
  • Participate in project management meetings and lead internal and external audits.

Requirements

  • Degree in life science or equivalent with a minimum of 3 to 5 years' experience in GDP.
  • Specialist knowledge and experience of pharmaceutical QMS processes and practices.
  • Excellent working knowledge of GDPs for the distribution of commercial medicinal products.
  • Fluent in English language and good level of Dutch - both verbal and written.

Physical Requirements

  • Ability to withstand long periods of sitting and use VDU equipment.
  • Flexibility to work late/early on rare occasions and limited travelling for internal/external meetings.

Key Competencies

  • Results Oriented, Sense of Urgency, and Flawless in Execution.
  • Good interpersonal and communication skills.
  • Good analytical and problem-solving skills.
  • Team working and self-starter with a good eye for detail.

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