Offer summary

Qualifications:

Bachelor's degree in a relevant field such as life sciences or quality assurance., Experience in quality management systems and regulatory compliance., Strong understanding of quality assurance processes and best practices., Excellent communication and training skills..

Key responsibilities:

Handle product release, return, and redressing activities to ensure compliance with regulations.

Support the implementation of Global Quality Management System and local SOPs.

Monitor and report key performance indicators related to quality standards.

Assist in managing inspections, audits, and ensure audit readiness.

Job description

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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.