
QA Specialist, HKBU
RemoteAt Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
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Job Description
• Handle Product Release, Product Return and Redressing activities for all products to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients in a timely manner.
• Support the local implementation of Global Quality Management System (QMS), Standards and Standard Operating procedures (SOPs) that are aligned with local requirements.
• Support ongoing compliance to the quality standards and procedures at the LOC. These include but are not limited to: change control, deviation, CAPA management, training, document management, complaint handling, etc.
• Local Documentation administrator to support the system operation, troubleshooting, document control etc.
• Local Training administrator for LOC Hong Kong, provide training and support to staff on quality assurance processes and best practices.
• Assist in the implementation of Supplier Quality Program at LOC Hong Kong according to Takeda Global Quality requirements and regulatory expectations (e.g., support management of quality agreements and qualification/auditing activities as applicable and assigned by line manager).
• Monitor and report key performance indicators (KPIs) according to Takeda Global Quality requirements, if needed.
• Assist in the management of inspections, audits, and self-assessments, and ensure LOC audit/inspection readiness.
• Assist in local Health Authority communication on product quality issues, if needed and when assigned by line manager.
• Assist in regulatory surveillance & intelligence in the LOC Hong Kong for new or emerging regulations.
• Support any GDP/GxP quality related activities across the LOC Hong Kong as required, depending on business needs as assigned by line manager.
• Demonstrate Quality Culture at LOC for a culture of continuous improvement and implementation of best practices.
Locations
China Remote LocationWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time#LI-Remote
Working at Takeda
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Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
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