QA Specialist, HKBU

Reposted 2 Days Ago
Be an Early Applicant
2 Locations
Hybrid
Mid level
Healthtech • Software • Analytics • Biotech • Pharmaceutical • Manufacturing
Takeda exists to create better health for people, brighter future for the world.
The Role
The QA Specialist handles product compliance, supports Quality Management Systems, manages documentation and training, and ensures audit readiness.
Summary Generated by Built In
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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

Top Skills

Document Management System
Quality Management System (Qms)
Standard Operating Procedures (Sops)

What the Team is Saying

Christina Alves
Lavanya Wadhwa
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The Company
HQ: Cambridge, MA
50,000 Employees
Year Founded: 1781

What We Do

For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. 

We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts.  

Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives.  

Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.  

Why Work With Us

We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.

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Hybrid Workspace

Employees engage in a combination of remote and on-site work.

Takeda's hybrid policy varies by role. Be sure to ask your recruiter about the requirements for the role that you are applying for.

Typical time on-site: Flexible
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