AstraZeneca Pharmaceuticals LP PCT - Qualification Engineer Lead in Wuxi, China
Process Controlled Transportation Qualification Engineer Lead
Location: China (Wuxi)
At AstraZeneca, we don’t follow the crowd and that means we don’t expect our people to either. To develop life-changing medicines we approach problems in a different way – agile and nimble, and focused on what our people need to make ground breaking discoveries.
2018 has seen the start of a new and exciting challenge for the new Global Logistics Function. We are bringing together all our logistics and distribution expertise to maximise our combined expertise to create clear and single accountability for product movements around the world, working to the best global standards.
In January 2018, we established a world leading Logistics Centre of Excellence to steer our organisation through changing environmental demands. Our new Global Logistics Function manages the way our products move around the world and will become a key part of the performance of our end to end supply chain.
We have developed a single Global Logistics Function which will be a world leader in the way we ship our products. As part of this new strategy we will be investing in our capability as an organisation, significantly raising the bar and we will have an extensive training and development programme for all our logistics colleagues.
As a Qualification Engineer, you will the subject matter expert in the qualification of storage and transportation systems, and temperature management for pharmaceutical products. You will be a key part of the logistics team that will define the global standards and processes for the storage and transportation of all AstraZeneca pharmaceutical product per product label temperature requirements, as defined by Good Distribution Practices (GDP). You will take responsibility for leading the operational implementation of these standards and processes around the world.
As part of this role you will develop, deploy and maintain standards and procedures for Controlled Temperature Transportation, Route Risk Assessments and Container, Lane and Carrier Qualifications ensuring that all are compliant with regulatory guidelines and GDP.
You will also co-ordinate simulated distribution and thermal profile testing of packaging materials and packaged components to ensure product quality in transit.
You will also support the development, selection and qualification of active and passive shipping solutions as well as serving as the business interface with 3rd party Packaging Qualification Testing Labs and suppliers of temperature-controlled shipping systems.
You will develop and maintain a change control process for containers, carriers, lanes and modes.
Take responsibility for introducing and standardising new transportation packaging solutions through the timely introduction and formal acceptance of the change by all manufacturing sites.
Sound understanding of Good Distribution Practices, Safety, Health & Environment and Standard Operating Procedures
Understanding of transport qualification, process validation, cold chain logistics industry standards and validation compliance
Good innovative problem solving / investigational skills
Experience in Business Process Management processes
Experience working with Logistic Service Providers
Fluent English ability
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country where the role is advertised.