QA Specialist, HKBU
応募 後で応募 求人ID R0152739 掲載日 05/23/2025 Location:Hong Kong, Hong Kong SARBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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