Huidige banen gerelateerd aan Senior Quality Assurance Specialist - Amsterdam, Noord-Holland - Kyowa Kirin
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Amsterdam, Noord-Holland, Nederland Kyowa Kirin VoltijdJob Title: Senior QA Logistics SpecialistOverviewThe 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...
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Senior Quality Assurance Specialist
2 maanden geleden
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.
- 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.
- 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.
- 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.
