Milan, Lombardy, Italy
Excellence in quality and customer satisfaction are at the core of everything I do. With a solid technical background in manufacturing processes gained across diverse industries and production settings, I bring a quality-driven mindset founded on critical thinking, risk management, and operational flexibility. I lead teams and support organizations in achieving ambitious business objectives by ensuring high performance standards, promoting continuous improvement and driving sustainable results. I believe that professional development, teamwork and meaningful relationships are the key ingredients for long-term success and outstanding performance.
Leading the Corporate Quality Assurance department in any area, including GMP, ISO, HACCP and Cosmetic GMP, ensuring the safety, quality and robustness of Ganassini products. Technical reference for all companies in the Ganassini group. Managing the Quality System ensuring all the process are in compliance with the applicable regulations: - PRRC according to MDR 2017/745 - Lead auditor in first/second part inspection; Notified bodies audit management - Qualification and Validation Compliance - Technology transfer management - Technical compliance in regulatory dossiers
- Management, approval, and continuous improvement of the whole documentation concerning the integrated Quality Management System according to GMP, ISO 13485:2016, MDR 2017/745 and HACCP and ensuring the conformity of the product. - Management of not conformities and Investigation leader - Medical Device Vigilance Responsible - Responsible Person related to product market release - Risk Management Responsible according to ISO 14971 - Pharmaceutical Warehouse Technical Director - Expertise in sterile processes - Cooperation, Verification and approval aspects concerning Regulatory dossiers and R&D project - Auditor leader in First/Second part audits and experience in audit performed by the authorities (GMP – ISO – MDSAP)
Cooperation with QA Responsible for managing the Quality System's documentation for drugs, nutraceuticals and medical devices - Medical Device Vigilance Responsible - Risk Management Responsible according to ISO 14971 - Pharmaceutical Warehouse Technical Director - Quality Technical Agreement editing - Expertise in sterile processes - Auditor leader in First/Second part audits and experience in audit performed by the authorities - Technical Supervisor in R&D’s product development and Technical writer for Regulatory dossier
Supervision and improvement of the Quality System in a new manufacturing department in order to guarantee the activities and the compliance according to the regulations - Technology Transfer activities: R&D to Production & Site to Site - Managing process according to Quality by Design approach - Experience in Product & Process Validation and Data Validation - Not conformity management (CAPA & Change Control actions) using Root Cause Analysis - Experience in authorities inspections and third parts Audit
Performing laboratory activities for research, development and production MD: - Industrial scale up and Pilot Batch Production - Knowledge of Analytical Protocols and Process Validation - Technology Transfer: R&D to Production (First level) - Development Project Leader of the first CLIA Kit Rubella IgG Avidity in European market
- Cooperate for managing the manufaturing process of Plasma-Derived in asepsis - Batch Record Review - Writing and editing of SOP, IOPQ and Cleaning Procedures