Department Head. Final release of labelled/packaged investigational medicinal products for clinical trials worldwide.FvP/RP Deputy

Final release of labelled/packaged investigational medicinal products for clinical trials worldwide. FvP/RP Deputy

Release of Investigiational Medicinal Products for human use and world wide distribution, QA Manager, Issue Manager, GMP Auditor, GMP Expert, Complaint Manager, Trackwise for Change Control & Discrepancies & CAPA, Regulatory Compliance, GMP Compliance, Project Management, SAP

The same responsibilities as Head just change to Expert after Process Organisation Orientation implementation (POO organization)

Responsible for the GMP approval of third parties for outsourced testing and raw material and consumables suppliers. Responsible for related change control management and deviations. Handling of change reaquests and deviations via Trackwise system.Responsible for raw material management. In charge of raw material approvaland release before use in production. Deviation management linked to raw materials.Experience with the elaboration of quality agreements with third parties and suppliers. Coordination of the site audit program (internal and external audits). Responsible for Inspections related CAPA plans.Coordination of Health Autorities inspections (FDA, ANVISA, AFSSAPS ect.). Inspection preparation, execution, writing of daily reports, and CAPA plan follow up.Responsible for the implementation and follow up of the actions linked to the Site Quality Risk Assessment and Quality Plan.

Responsible for all qualifcation for Utilities-support equipment and HVAC during the construction of the new facility for the Basiliximab production.Design and implementation of the equipments qualification strategy for the WFI, purified water, steam and gas systems. Strategy definition for the HVAC system qualification and outsourced testing. Responsible for the release of support equipment (washing machine, laminar et isolator) as required by the protocol and users´ requirements.

Sampling plan management. Responsible for the microbiological testing transfer from PharmOps site to BiotechOps site. Responsible for the environmental data, bioburden testing done in the manufacturing area, trending, and handling of out of specifications. Responsible for the stability management.