Senior Quality Assurance Executive

4 days ago


Ho Chi Minh City, Vietnam Takeda Pharmaceutical Full time

**Job Summary**:
**The job requires the incumbent to provide quality operations in the Vietnam Local Country and is responsible for ensuring quality compliance of the local GxP activities. The incumbent in this role works in close partnership with local stakeholders to support Vietnam’s strategy while maintaining compliance with Health Authority regulations and Takeda’s quality requirements.**:
**Key & Responsibilities & Accountabilities**:

- ** Implement Takeda QMS and ensure ongoing compliance with quality standards and procedures. Setting up local QMS as required by Local regulations.**:

- ** Implement the Quality Plan in Vietnam**:

- ** Ensure Quality Council is conducted periodically.**:

- ** Implement the Supplier Quality Program at the LOC in accordance to Takeda Supplier Quality Management expectations. These would encompass the selection & qualification of new suppliers, ongoing quality performance monitoring, and exit of suppliers which provide materials and services with GxP/product quality impact. Ensure new GxP suppliers/contractors are audited and qualified before use. Lead or participate in quality audits, & support QA due diligence of new business partners according to local regulatory requirements**:

- ** Accountable for and oversee the management of local Quality activities to support Quality operations.**:

- ** Quality activities include but not limited to product release, complaints handling, deviations, change controls self-inspection, training, control of GxP documentation, quality risk management, in-country testing requested by the health authority, support new product launches, quality oversight of local GMP/GDP activities, etc**:

- ** Local release: Ensure batch release (SAP systems) is in compliance with local regulatory requirements and local procedures prior to distribution.**:

- ** Evaluate returned goods and ensure that damaged and expired materials are properly destroyed**:

- ** Checks the quality of packaging materials, from artwork development up to the finished product**:

- ** Organizes / partakes in internal audits (self-inspection) in cooperation with other functions**:

- ** Ensures that changes with an impact on quality, safety, and registration status of products are being reviewed, approved, and authorized prior to implementation**:

- ** Ensure all relevant LOC colleagues performing GxP quality-related tasks are appropriately trained prior to perform activities.**:

- ** Ensures proper documentation and archiving of QMS documents, along with maintaining traceability**:

- ** Ensures gap assessment on global procedures applicable to the LOC is being done timely**:

- ** Reviews adverse event reporting made by the Pharmacovigilance team monthly by conducting a random check**:

- ** Performs other tasks and duties which may be assigned by the immediate supervisor from time to time**:

- ** Provide quality expertise and resolution of all product quality issues originating in the LOC in conjunction with other functions (ie. Regulatory Affairs, Medical, Business Unit, GMS). Timely escalation of reportable events in accordance with Takeda Global process.**:

- ** Participate and lead the implementation of integrated GxP enterprise systems (TrackWise, SAP, etc).**:

- ** Influence LOC Quality strategy cascaded from Global Quality Roadmap, and align to LOC Business Plan**:

- ** Drive and strengthen the Quality Culture**:
**Qualification / Attributes**:

- ** University Degree or Bachelor of Science Degree in Pharmacy or Industrial Pharmacy**:

- ** Pharmacy professional license holder**:

- ** A minimum of 3-5 years of relevant Quality expertise in the pharmaceutical industry**:

- ** Competencies**:

- ** Ability to think strategically and identify a vision along with the plans which need to be implemented to meet the end goal**:

- ** Ability to develop and maintain relationships with internal and external business partners**:

- ** Must be comfortable having constant communication with stakeholders within Vietnam LOC.**:

- ** Strong communication skills with various levels of the organization**:

- ** Ability to assess and make risk-based decisions while keeping stakeholders appraised**:

- ** Experienced in assessing a situation, identifying issues, and developing solutions that result in efficiencies or process improvements**:

- ** Ability to work with a sense of urgency, prioritize work, and meet objectives/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**:

- ** Strong project management skills with the ability to work independently and within a team**:

- ** Ability to adjust work schedule based on business**:
**Locations**:
Ho Chi Minh City, Vietnam

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full



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