As a member of the External & Clinical Supply Quality team, the Clinical Supply Quality Support is responsible for, but not limited to the QA review of IMP batch records, ensuring the prompt resolution of all batch manufacturing issues and ensuring close out of development related CAPAs. This role provides direct partner driven, pragmatic and proactive support for development manufacturing.
The Clinical Supply External Operations Quality Partner is responsible for QA release support during regulatory inspections, and quality improvement initiatives.
In addition, the Clinical Supply External Operations Quality Partner is responsible for ensuring that appropriate quality systems are in place for the production and release of IMP for Clinical trials as required by the development team.
The Clinical Supply External Operations Quality Partner is responsible for ensuring that: appropriate quality systems are in place for the internal and external provision of client's products and services, the resolution of manufacturing issues, support during regulatory inspections, active participation in the selection, evaluation, approval and maintenance of vendor and also for quality improvement initiatives. He is also responsible for developing a partnership approach to support the different departments.