Site Quality Manger

4 weeks ago

Ho Chi Minh City, Vietnam Sanofi Full time

**Job title**:_Site Quality Manager _**
- _Location: Long Hau Warehouse _
- _% Remote working and % of travel expected: N/A _
- _Job type: Full time _

About the job

**Our Team**:

- _Quality Mission: We strive to be a trusted partner, operating in compliance with regulations and managing quality processes powered by data-driven science, to address patient needs _
- _Function Purpose: To provide safe and effective products and services throughout the distributed and marketed network in compliance with the regulatory requirements and our Company values. _

**Main responsibilities**:

- _Be a Qualified Person for business of import and export of medicine, biology and vaccine products. Be responsibility for all pharmaceutical activities at site including compliance with Regulation and Quality of product. _
- _Be responsible for making quality decision in receiving, releasing products or doing the task delegation to equivalent education staff. _
- _Verification that program and systems are implemented to consistently identify, analyse, evaluate, control and review potential or identified risks related to quality and compliance _
- _Review and approval of changes that could potentially impact the quality of the product _
- _Approval of subcontractors and suppliers involved in GxP activities, and maintenance of their approved status, including quality assessments, audits and approval of quality agreements. _
- _Verification that the quality training and personnel qualification programs are managed according to Sanofi, GSP and regulatory requirements. _
- _Verification that effective systems are used for the maintenance and calibration of critical equipment and instrumentation. _
- _Verification that facilities, utilities, equipment, manufacturing processes, cleaning processes, computerised systems, and transport processes are qualified or validated when needed _
- _Monitoring progress on quality-related corrective and preventive actions to assure timely compliance and improvement _
- _Investigation on deviations, failures, out-of-trends, product technical complaints/ logistics complaint and coordination of product recalls _
- _Management of return before resale _
- _Management of quality documentation, including review and approval of documentation with a GxP impact. _
- _Preparation, organisation and monitoring of regulatory inspections _
- _Conduct of self-inspections of site facilities, operations, procedures and systems to ensure conformance with GSP and related regulatory requirements _
- _Supply Chain Compliance process _
- _Review and update internal/ external policies to Supply Chain team. _
- _Identify potential risk, ensuring the local/ global regulation/ procedure/ guidelines to be deployed to the Supply Chain team and ensuring the CAPA in place with compliance gaps identified. _
- _Maintain monthly compliance health check to of whole Supply Chain team. _
- _Coordinate with Internal Control to manage internal audit that involving Supply Chain activities _

About you
- **_Experience _**_: P _rofessional experience in Quality in GSP Warehouse, professional experience in a foreign country. _
- **_Soft skills _**:

- _Dynamic, smart, proactive _
- _Sharp working in data management _
- _Good communication _
- _Analytical & accuracy skills _
- _Well-organized & process oriented _
- **_Technical skills _**_: _
- _Business analysis/ Distribution Channel including financial flow and physical flow _
- _Proficiency in MS Office, knowledge in SAP is a plus _
- **_Education _**: _Pharmaceutical degree with pharmaceutical practice certificate in scope of medicine, vaccines and biology import and export _
- **_Languages _**_: _Fluent in English (oral & written communication) _

Sanofi Behaviors and Skills

This position is required to demonstrate behaviors such as Stretch, Put the interest of the organization, Act in the interest of our patients and customers and Take Action. During the interview we will also be asking for examples of skills such as Strategic Thinking, Result Orientation, People Leadership (if applicable), Relationship and Influence.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

LI-SEA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We resp

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