Senior QA Executive

3 weeks ago


Ho Chi Minh City, Vietnam Adecco Full time

**Job summary**:
Our client, a global science-driven biopharmaceutical leader, is looking for Senior QA Executive working in Ho Chi Minh City

**Responsibilities**:

- Implement QMS and ensure on-going compliance to quality standard and procedure. Setting up local QMS as required by Local regulations.
- Implement the Quality Plan in Vietnam
- Implement Supplier Quality Program in accordance to Supplier Quality Management expectation. 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 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 health authority, support new product launches, quality oversight of local GMP/GDP activities etc
- Organizes / partakes in internal audits (self-inspection) in cooperation with other functions
- Ensures that changes with impact on quality, safety, and registration status of products are being reviewed, approved, and authorized prior to implementation
- Ensure all relevant local colleagues performing GxP quality-related tasks are appropriately trained prior to performing activities.
- Ensures proper documentation and archiving of QMS documents, along with maintaining traceability
- Ensures gap assessment on global procedures applicable to the Local is being done timely
- Reviews adverse event reporting made by the Pharmacovigilance team monthly by conducting random check
- Provide quality expertise and resolution of all product quality issues originating in the LOC in conjunction with other functions Timely escalation of reportable events in accordance with Global process.
- Participate and lead the implementation of integrated GxP enterprise systems (TrackWise, SAP etc).
- Influence local Quality strategy cascaded from Global Quality Roadmap, and align to Business Plan.

**Experience requirements**:

- 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
- 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 to have 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, 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
- Strong project management skills with the ability to work independently and within a team
- Ability to adjust work schedule based on business

**Education requirements**:
**Contact Person**:
Linh Hoang

Adecco


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