Act as one of the releasing QPs for Vaccine Products for which Janssen Biologics is either the Marketing authorization holder or is filed as Release Site.
Provide QA support for multiple External Manufacturers supplying product to or exporting through the EMEA region. Contribute to the overall development, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecule products.
The position requires solid knowledge in all quality systems concerning the manufacture of drug products and extensive knowledge of Quality Assurance, Quality Control and Compliance.
Ability to manage multiple and/or complex External Manufacturers. Demonstrated ability to take ownership for and lead the resolution of Quality and Compliance issues.
Execute the duties and roles of a QP:
Serve as a contact point within the QA organization of other departments of both Janssen and the external manufacturer with respect to quality relevant subjects.
Ensure that all relevant QA related concerns at the external manufacturer’s sites are raised to Janssen management. Ensure that the manufacturing operations for Janssen at the external manufacturer site run smoothly from a QA point of view and in a compliant manner.
Review batch documentation of products in scope prior to release and completion of the Lot release protocol.
Pro-actively identify risks and potential issues and delays and, where possible, resolve them. Where resolution is not possible, escalation to the relevant level of management is necessary.
Review and monitor customer complaints in the respective database. Interaction with the complaint handling department of the external manufacturer to follow-up on investigations; secondary review of serious complaints
Meer info of solliciteren? KLIK HIER