QA Specialist, HKBU

Takeda; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Assurance professional to ensure compliance with product quality standards and local regulations. The role involves managing product release activities, supporting quality management systems, and training staff on quality assurance processes. Candidates should have a relevant degree and experience in QA within regulated environments.

Qualifications

• 3 years’ experience in pharmaceutical companies in QA and GxP regulated areas.
• Fluent in written and spoken English and Chinese.
• Self-motivated quick learner.

Responsibilities

• Handle Product Release, Return, and Redressing activities.
• Support local implementation of Global Quality Management System.
• Assist in the management of inspections, audits, and self-assessments.

Skills

Critical Thinking

Problem Solving

Good Communication

Risk Management

Continuous Improvement

Education

Bachelor’s degree in Pharmaceutical Science

Bachelor’s degree in Biomedical Science

Bachelor’s degree in Life Science

Job description

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 China Remote Location Worker Type Employee Worker Sub-Type Regular Time Type Full time