QA Specialist, HKBU

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Job Description

ACCOUNTABILITIES

•    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.

Qualifications & Skills

•    Bachelor’s degree in Pharmaceutical Science, Biomedical Science, Life Science or a related field.
•    3 years’ experience in pharmaceutical companies in QA and GxP regulated areas.
•    Understanding of local applicable laws and regulations related to QA.
•    Fluent in written and spoken English and Chinese.
•    Self-motivated quick learner
•    Critical Thinking, investigation and problem solving
•    Good communication skills 
•    Ability to manage complexity & balance priorities
•    Risk identification, evaluation, and management
•    Continuous improvement
•    Highest ethical standards

Locations

HKG - Hong Kong Commercial

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time