Quality Assurance Specialist

3 weeks ago

Ho Chi Minh City, Vietnam NVS Vietnam Company Limited Full time

As a Quality Assurance specialist, you will ensure that all quality-relevant processes within the Vietnam Country Organization are stays in sync with applicable regulations and standards and provide quality oversight and governance to ensure that the Vietnam Country Organization meets its quality objectives as well.
- Implement and ensure effective Quality oversight and adherence to the Quality Plan within the Vietnam Country Organization. This includes ensuring compliance with Marketing Authorization and Standard Operating Procedures (SOPs) for commercial batch release.
- Manage change control, deviation management, artwork control, risk assessment, training management, SOP system management, complaint/return/recall/counterfeit management, and handling of quality-related customer inquiries in an effective manner.
- Establish a regular review and assessment of Key Quality Indicators (KQIs) at the Quality Committee.
- Lead third-party activities such as audits, Corrective and Preventive Actions (CAPA), deviations, and change control.
- Ensure timely delivery of all quality services while maintaining compliance with cGxP, legal, regulatory requirements, and Sandoz Quality Manual and Policies.
- Enhance Quality Assurance (QA) support to prevent supply interruptions.
- Provide quality oversight to ensure warehouse operations stay in sync with Good Storage Practices (GSP), Sandoz Vietnam, and Global SOPs. Ensure accurate record documentation and archiving during warehouse operations.
- Control the implementation of goods receiving, storage, redressing (if applicable), and issuing procedures at the warehouse to align with GSP, company requirements, SOPs, and ensure timely product handover to wholesalers.
- Coordinate and perform sampling and quality checks on incoming goods and redressing materials, including evaluating shipment transport temperature, conducting duty of care checks, taking photos, generating deviation reports, notifying inspection results, archiving documents, and ensuring compliance with redressing processes.
- other authorized assignments, projects, and relevant tasks as required.

SANDOZ
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**What you’ll bring to the role**:

- Bachelor's degree in a scientific or technology field (e.g., chemistry, pharmacy, or other life science) with an advanced degree preferred.
- + 2 years of experience in the Pharmaceutical Industry, specifically in Quality Commercial/Quality Operations/Manufacturing.
- Proven track record to build positive relationships with management and other business stakeholders.
- Demonstrate history of leadership in operational roles related to quality across multiple sites.
- Proven self-starter with experience in initiating and delivering high-impact projects and processes across geographically and functionally complementary teams.
- Outstanding facilitation skills for linking between scientific and business partners, and for managing effective and successful international and cross-divisional collaborations.
- Proficiency in both spoken and written English and Vietnamese

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, innovative production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

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