Quality Assurance Specialist

At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0123290 Date posted 05/16/2024 Location Ho Chi Minh City, Ho Chi Minh

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Job Description

Job Title: Quality Assurance Specialist (Contract)
Location: Vietnam

About the role:

The job requires the incumbent to ensure compliance of GxP activities in accordance to Takeda Global Quality Standard and local regulations. The incumbent will support QA Manager on supplier quality oversight management, local product releases and resolution of quality issues at LOC.

How you will contribute:

• Support in implementation of QMS, Country Quality Plan in Vietnam
• Support in Supplier Quality Oversight of GxP activities, ie audits supplier, warehouse qualification, third party distributors and wholesaler, and warehouse self-inspection, ensuring adherence to GDP, QMS, and regulatory requirements.
• Incoming goods checking to ensure good quality and maintain process to ensures that damaged and expired materials are properly destroyed.
• Manage the process of Deviation & CAPA. Ie Deviations are reported, investigated, resolved, and documented.
• Ensures that changes with impact on quality, safety, and registration status of products are being reviewed, approved, and authorized prior to implementation.
• Ensures that GSP operation SOPs are aligned with QMS standards and local regulation.
• Responsible for the management of proper documentation and archiving of QMS documents, along with maintaining traceability – work as document coordinator for local GxP document.
• Work as back-up complaint initiatior.
• Performs other tasks and duties which may be assigned by the immediate supervisor from time to time.

What you bring to Takeda:

• University Degree or Bachelor of Science Degree in Pharmacy or Industrial Pharmacy.
• Pharmacy professional license holder
• A minimum of 3 years of relevant Quality expertise in the pharmaceutical industry.

Competencies

• Ability to develop and maintain relationships with internal and external business partners.
• Must be comfortable to have constant communication with stakeholders within Vietnam LOC.
• Ability to identify and assess risk.
• Experienced in assessing a situation, identifying issue, and risk
• Ability to work with a sense of urgency, prioritize work, meet objective / deadlines with strong organizational capability.
• Successfully demonstrated ability to coach others with a strong self-awareness (both strengths and opportunities) and ability to self-develop.
• Ability to adapt to change and work flexibly to overcome boundaries.
• The ability to work independently and within a team.
• Ability to adjust work schedule based on business.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations Ho Chi Minh City, Vietnam Worker Type Employee Worker Sub-Type Fixed Term (Fixed Term) Time Type Full time