Didier RODENAS

Suppliers’ quality management
Lifecycle management
Good Scientific Practices (GSP) application in the Devices and Packaging Laboratory
UCB Quality Management System processes
Support in authorities’ inspections

Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples.
Supports Validation Experts to assess need and plan validations / re-validations / verifications/Annual Monitoring Batches, consulting approving and reviewing the process validation master plan, together with Validation Experts.
Responsible for the coordination of the validation of raw material projects
Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams.
Actively participate and represent their product(s) & processes in the relevant committee, where the improvements on weak point products are planned, prioritized and monitored.
Ensure that pack component issue from the production are managed: all issues are treated in collaboration with the appropriate departments
SPT (Site Product Technologist): management of artwork and approval of specifications and drawings of pack components.

Manage relationship with suppliers to ensure achievement of GSK quality requirements.
Manage quality aspects of materials’ qualification and life-cycle activities.
Perform investigations in partnership with GSK stakeholders and suppliers (root cause analysis, product impact assessments and CAPA definitions in the frame of deviations/market complaints).
Manage supplier change notifications for appropriate review and implementation.

Packaging project for primary, secondary packaging and temp chain articles

Packaging development for worldwide projects.

Packaging Development (bottles, airless, applicators, tubes), team work with R&D, Marketing, Methods etc. for global projects (US, Japan, Europe)

Packaging Engineer - Packaging development for bottles, tubes, folding boxes. Value analysis for key products.