Dr. Luigi De Rosa

Responsible for the implementation of Quality Operations (Quality Assurance and Quality Control) policies, supporting external parties/partners and alliances (EP’s) for manufacture, testing, packaging, storage, and distribution of sterile pharmaceutical products, API intermediates, API, non-sterile pharmaceutical products,biologics, drug delivery devices and consumer care products.

Managed the relationship with assigned suppliers in EU and Asia from a Quality perspective to ensure that all aspects of the products comply with the requirements of the GSK Quality Manual and meet relevant cGMP, regulatory and legislative requirements, through defined key performance and quality indicators.

Primary point of contact for all Quality Related Items/Issues with Manufacturing Sites and Aspen Affiliates worldwide (deviations, OOS/OOE, complaints, CAPA, recalls, counterfeits and product tampering, stability failures, etc.).

Acted as Single Point of Contact (SPOC) for all quality related activities at the Third Party Suppliers, ensuring that all aspects of the handling, manufacturing and distribution of pharmaceutical products were in compliance with relevant cGMP, regulatory requirements, the Novartis Quality Manual and the effective Quality Agreements.

Issue and Review of Quality Procedures and SOPs. Batch Record review. GMP documents review and approval. GMP compliance activities for Active Pharmaceutical Ingredients (API) and food products: change control management, deviations, review of deviation investigation reports. Review of specifications and analytical methods of raw materials, finished and intermediate products. Execution of Self-Inspections Audits. Support for FDA Regulatory Inspections preparation and management.

Implemented quality, environment and safety management systems for manufacturing and service companies. Realized Hazard Analysis and issued HACCP manuals and food safety management systems for food manufacturing and retailers. Performed environmental consulting (focused on waste management, noise, air emissions, water discharges). Executed both internal and external audits of management systems of different types of companies.

• Molecular characterization of bacterial communities involved in the “Toscano” cigar fermentation. • Design, management and execution of research projects particularly in the molecular biology and microbiology fields.

Progettazione, gestione ed esecuzione di progetti di ricerca. Produzione ed ibridazione di micro e macro arrays per Gene Expression e per identificazione di SNP. Diagnostica molecolare per mezzo di MALDI TOF. Sequenziamento DNA. Automazione di laboratorio (messa a punto dei protocolli per Biomek 2000, Colony Picker, Microarray Spotter).

Molecular and Industrial Biotechnologies

Industrial Biotechnologies