Senior Quality Assurance Specialist

3 weken geleden

Amsterdam, Noord-Holland, Nederland Kyowa Kirin Voltijd
Job Title: Senior QA Logistics Specialist

Overview

The Senior QA Logistics Specialist will be responsible for ensuring the quality and compliance of medicinal product distribution activities within the EMEA region. This includes ensuring adherence to GDP/GDP-API & GMP requirements, managing supplier and customer verification, and executing quality assurance of stock management.

Responsibilities

  • Ensure the implementation and maintenance of Kyowa Kirin's Quality Management Systems (QMS) for medicinal product distribution activities.
  • Contribute to the development and implementation of quality policies and procedures for distribution activities.
  • Manage supplier and customer verification, including onboarding and offboarding, contractor risk assessment, and quality technical agreements.
  • Execute quality assurance of stock management, including QA oversight of inbound and outbound activities, non-conformities, returns, and stock reconciliation.
  • Monitor the quality performance of distribution contractors and propose actions for improvement.
  • 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 progress and identify areas for improvement.
  • 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.

Qualifications

  • 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.
  • 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 or early on rare occasions.
  • Limited traveling for internal and 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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