Senior Quality Assurance Specialist

1 week 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 product distribution activities in the EMEA region.

Key Responsibilities

  • Ensure compliance with GDP/GDP-API & GMP requirements for the distribution of medicinal products.
  • Contribute to the implementation of Kyowa Kirin's 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 of the established QMS to support continuous 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 and Kyowa Kirin QA Policies/Procedures.
  • Raise appropriate change controls following quality risk management principles.
  • Lead investigations of distribution/supply non-conformities, deviations, and temperature excursions.

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.
  • Experience of working within the pharmaceutical industry operating in a Quality Assurance position at a manufacturing/distribution site.
  • Excellent working knowledge of GDPs for the distribution of commercial medicinal products.
  • Effectively working with cross-functional teams at a local and regional level.
  • Good technical writing and editing skills.
  • Fluent in English language and good level of Dutch - both verbal and written.

Physical Requirements

  • Ability to withstand long periods of sitting.
  • Ability to use VDU equipment, read and focus intently for long periods of time.
  • Flexibility needed with regards to rare occasions where working late/early might be required.
  • Limited travelling (local and international) might be needed 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.
  • Ability to operate in a 'virtual' pharmaceutical environment.

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