Senior Quality Assurance Specialist

2 maanden geleden

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

We are seeking a highly skilled Senior QA Logistics Specialist to join our team at Kyowa Kirin International. As a key member of our Quality Assurance department, you will be responsible for ensuring the compliance of our medicinal product distribution activities with GDP/GDP-API & GMP regulations.

Key Responsibilities
  • Ensure the effective implementation of Kyowa Kirin's Quality Management Systems (QMS) in medicinal product distribution activities.
  • Contribute to the compliance of our distribution activities with GDP/GDP-API & GMP requirements.
  • Execute supplier and customer verification management, including onboarding, offboarding, and contractor risk assessment.
  • Oversee Quality Assurance of Stock management, including QA oversight of Inbound/Outbound, non-conformities, returns, and stock reconciliation.
  • 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.
  • Raise change controls following quality risk management principles.
  • Investigate 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 working within the pharmaceutical industry in a Quality Assurance position at a manufacturing/distribution site.
  • Excellent working knowledge of GDPs for the distribution of commercial medicinal products.
  • Effective 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 to work late/early on rare occasions.
  • Limited travelling 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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