Pasqualino Ferrante

Background

About Pasqualino Ferrante

Quality Assurance and Manufacturing Science & Technology Specialist with experience in ensuring product excellence in the manufacturing of sterile formulations for human use. Solid experience in managing deviations, CAPA, Change Control and process validation. Skilled in liaising with multifunctional teams and managing improvement projects. Graduated in Pharmacy, with experience in structured and dynamic environments. • Managed and analyzed process deviations, implementing timely corrective actions to improve quality. • Coordinated continuous improvement projects in collaboration with various company functions, focusing on process optimization and adherence to quality standards. • Experience in managing CAPA (Corrective and Preventive Actions) and Change Control, regularly updating related documentation. • Reviewed Batch Records to ensure compliance with quality requirements and standards. • Person in plant to the CMO sites for validation activities supervision. • Managed Risk assessment and validation exercises. • Supported internal and external audit activities, analyzing deviations and proposing corrective solutions. • Contributed to the definition and implementation of process standards to improve product quality and ensure regulatory compliance. • On the floor oversight of process qualification in Moderna Australia plant (three weeks business trip). • Managed Single Use Systems activation and qualification at the manufacturing site, including (but not limited to): code creation and activation, Materials URS issuing and approval, Material Risk Profile definition and approval, Material Validation Master Plan issuing and approval, material specification review.