Huidige banen gerelateerd aan Senior Quality Assurance Specialist - Amsterdam, Noord-Holland - Kyowa Kirin
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Amsterdam, Noord-Holland, Nederland Kyowa Kirin VoltijdJob DescriptionAt 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...
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Amsterdam, Noord-Holland, Nederland Kyowa Kirin VoltijdJob SummaryWe 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 products distributed in the EMEA region.Key ResponsibilitiesEnsure compliance with GDP/GDP-API & GMP requirements for the distribution of medicinal...
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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 GDP/GDP-API & GMP requirements for the distribution of medicinal products into the EMEA region.
- Execute supplier and customer verification management, including onboarding, offboarding, contractor risk assessment, and quality technical agreements.
- Oversee the quality assurance of stock management, including inbound, outbound, non-conformities, returns, and stock reconciliation.
- Monitor the quality performance of distribution contractors and propose improvements as needed.
- Drive continuous improvement activities of the established QMS 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 and lead internal and external audits to assess adherence to GMP/GDP/GDP-API product distribution requirements.
- Raise change controls following quality risk management principles and lead investigations of distribution/supply non-conformities.
- 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.
- Fluent in English language and good level of Dutch - both verbal and written.
- Ability to withstand long periods of sitting and use VDU equipment.
- Flexibility to work late/early on rare occasions and 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 and self-starter with a good eye for detail.
