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The Product Traceability team is responsible for all activities associated with Product Traceability and Serialization within Alexion AstraZeneca Rare Disease Unit (RDU). This is a business-critical role, as the decision maker holds overall accountability for Product Traceability and ensuring compliance to the market traceability requirements (examples EU, US, Russia, China). You will be integral to ensuring product traceability systems, processes and standards are developed, implemented and tested while maintaining alignment with global standards and compliance regulations.
The role involves the day-to-day support of all Alexion product traceability and serialization related activities. This role will require cross-functional collaboration within Alexion RDU Operations in all aspects of serialization and product traceability as well as other AstraZeneca business units. Operations includes, but are not limited to, Packaging, QA, Warehouse & Distribution, Internal and External Manufacturing teams, and Global Supply Chain Operations.
In addition to daily operations support, the role will include leading key business projects for product traceability and integration projects (onboarding of CMOs, downstream partners, and new markets). Assume the role of subject matter expert within the area of serialization and product traceability. Troubleshoot and support the business with respect to serialization and associated processes.
Principal Responsibilities
* Responsible for the maintenance and management of master data within tracelink.
* Responsible for the various product traceability processes (alert management, release management, market regulatory compliance, security features).
* Responsible for the maintenance and management of all traceability SOPs across global operations.
* Conduct regular auditing of the process to ensure ongoing accuracy and compliance.
* Manage alerts that arise for the EU and oversee timely resolution.
* Work closely with IT, packaging (internal and external), and Global Supply Chain and understand the effect of process and system changes on product traceability.
* Attend global team meetings.
* Participate in industry work groups on discussions relating to traceability market requirements.
* Define and deploy a serialization strategy for the Alexion RDU that is fully aligned to the AstraZeneca strategy.
* Represent Alexion RDU on the AZ Security Council and be responsible for rolling out security features across the Alexion business.
Qualifications
* 4+ years proven track record in pharmaceutical/biotech/manufacturing Supply Chain environment.
* 2+ years serialization-related or product traceability experience.
* Possess a good knowledge of the pharmaceutical packaging process and the support functions of the supply chain (Artwork/Labelling, IT, Distribution, etc).
* Ability to cope with fast-paced and dynamic business environment.
* Awareness of the regulatory landscape associated with serialization and product traceability (EU FMD, DSCSA).
* Understanding of packaging line processes and technology.
* Experience and knowledge of distribution processes preferably associated with product traceability.
* Computerized system and associated process ownership experience.
* Knowledge of cGMP and associated traceability regulatory considerations in a pharmaceutical environment.
* Strong communication and collaboration skills.
* Ability to interact with all levels of the organization.
* Ability to influence both internal and external partners.
* Detail-oriented with the ability to effectively manage multiple competing priorities.
* A team player who will actively contribute to process optimization discussions and to maintaining an inclusive work culture.
* Mental resilience, an ability to work under pressure and to navigate through ambiguity.
Date Posted: 29-Jan-2025
Closing Date: 28-Feb-2025
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
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