By 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’s Privacy Notice and 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 **Locations** HKG - Hong Kong Commercial **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time