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Janssen Pharmaceutica NV, a member of Johnson & Johnson's Family of Companies, is recruiting for a QA Release Associate for our European Distribution Network (EDN)!
As a QA Release Associate in Beerse Belgium, you will:
The EDN Quality Assurance team is a dynamic and motivated team supporting the distribution processes of Janssen products in the EMEA region from manufacturing to central hubs, worldwide distribution center's and towards the end-customer.
The function holder will be key user representing the Network and Deliver Pharma DCs for Batch Management and Quality related processes, and will drive continuous process improvements within the following areas:
The responsibilities and the impact YOU will have:
- Perform logistic release in SAP for External Manufactured batches received in our central European warehouse as well as JPNV representative for our local Distribution Center in Czech Republic.
- Support Artwork Management process, ensuring artwork identification via Version Management reports, collaborating closely with LOC QA and MAKE QA as appropriate
- Govern Country Restrictions process, ensuring compliance when shipping non-registered products worldwide
- Coordinate, as Key QA contact in the Network, for LOC QA, Customer Management and Manufacturing partners, handling requests as applicable, through priority list or other inputs.
- Provide master data input (eg. version management & retention sample)
- Keep oversight of IT investigations related to release and batch management process. Support DC QA teams and LOC QA teams developing an E2E collaboration.
- Participate in projects related to QA release processes
- Handle EDN Quality records (non-conformances, CAPA and Change Controls)
- Actively support EDN Operation team in their daily business activities.
We would love to hear from YOU, if you have the following essential requirements:
- Scientific Master’s degree
- Extensive QA related experience within an operational pharmaceutical environment
- cGMP/GDP knowledge
- Experience in using SAP Europe 2 or Warehouse Management System
- Experience in Quality Management Systems for Deviation, CAPA, Change control System, Document control (systems: Trackwise ETS; truVault)
- Experience in IT investigation / User Acceptance testing (systems: Jira)
- Proficient in English, both verbal and written
- Problem solver – structured & analytical way of working, knows the priorities
- Curious, autonomous, continuously looking for improvement
- Phenomenal teammate, able to build positive relationships with internal and external customers
- Confident, organized, persistent and assertive.
