Senior Quality Assurance Specialist

2 weken geleden

Amsterdam, Noord-Holland, Nederland Kyowa Kirin Voltijd
Job Description

At Kyowa Kirin, we are seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our logistics and compliance team, you will be responsible for ensuring the quality and integrity of our medicinal products distributed in the EMEA region.

Key Responsibilities:

  • Ensure compliance with GDP/GDP-API and GMP requirements for the distribution of medicinal products.
  • Participate in the implementation and maintenance of our Quality Management Systems (QMS) to ensure seamless distribution activities.
  • Execute supplier and customer verification management, including onboarding, offboarding, and contractor risk assessment.
  • Monitor the quality performance of distribution contractors and propose improvements as needed.
  • Drive continuous improvement activities to support compliance with established licenses.
  • Implement Kyowa Kirin QA Global Policies and Global/Regional Procedures/Documents relevant to distribution activities.
  • Ensure prompt and professional communication of key issues to senior management.
  • Participate in project management meetings to ensure the progress of ongoing tasks.
  • Lead internal and external audits to assess adherence to GMP/GDP/GDP-API product distribution requirements.
  • Raise appropriate change controls to ensure compliance with applicable regulations and QMS policies.
  • Investigate distribution/supply non-conformities, deviations, and temperature excursions, and implement corrective actions.

Requirements:

  • Degree in life science or equivalent with a minimum of 3-5 years' experience in GDP.
  • Specialist knowledge and experience of pharmaceutical QMS processes and practices.
  • Experience working within the pharmaceutical industry in a Quality Assurance position.
  • 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 using VDU equipment.
  • Ability to read and focus intently for long periods of time.
  • Flexibility to work late/early on rare occasions and limited traveling for internal/external meetings.

Key Competencies:

  • Results Oriented, Sense of Urgency, and Flawless in Execution.
  • Takes responsibility for ensuring key deliverables.
  • Good interpersonal and communication skills.
  • Good analytical and problem-solving skills.
  • Team working.
  • Self-starter with a good eye for detail and ability to complete tasks/objectives.

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