Luigi De Rosa

Luigi De Rosa

API Quality Manager CMO, GSK Consumer Healthcare

I'd like to develop my professional network
 

Currently employed at GlaxoSmithKline

Previous: Aspen Global Incorporated, Novartis, DSM, Associazione dei Professionisti della Qualità, British American Tobacco, Fiuotecnica srl

 

Previous: Università Degli Studi Di NAPOLI Federico II

 

    Summary

    • Biotechnologist with multidisciplinary expertise, enthusiastic and passionate about Pharmaceutical Quality Assurance. • Achieved considerable pharmaceutical experience in quality related activities for ensuring the compliance with relevant cGMP and regulatory requirements of all the aspects of the handling, manufacturing and distribution of pharmaceutical products and API working within multinational corporations as a primary quality contact with worldwide-based Contract Manufacturing Organizations and suppliers. • Very competent at handling multiple tasks, assigning priorities and controlling multiple projects and resources simultaneously under tight deadlines. • Strong analytical and problem solving skills. Action oriented, forward looking and a quick and intuitive thinker. Member of Mensa (the high IQ society) • Experienced in working within multicultural environments in different parts of the world, with colleagues having different experiences and professional needs. • Excellent communication, interpersonal, collaboration and negotiation skills

Experiences

 

API Quality Manager CMO

At GlaxoSmithKline

From April 2016 to Present
• Managing 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...
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Senior Quality Assurance Associate

At Aspen Global Incorporated

From September 2014 to March 2016
• 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.).
 

Quality Assurance Specialist TPO Europe

At Novartis

From January 2013 to August 2014
• 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...
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Quality Assurance

At DSM

From November 2011 to December 2012
* Achieved Good Manufacturing Practices (GMP) compliance activities for Active Pharmaceutical Ingredients (API) and food products: change control, deviations, review of deviation investigation reports. * Issued Master Batch Records and reviewed manufacturing batch records. * Delivered and reviewed...
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Consultant for Quality, Environment and Food Safety MS

At Associazione dei Professionisti della Qualità

From March 2006 to October 2011
* I founded my own consultancy company and established collaborations with a network of professionals. * Implemented quality, environment and safety management systems for manufacturing and service companies. * Coordinated the suppliers’ validation team for qualification activities, inspection...
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Ricercatore

At British American Tobacco

From 2004 to 2005
Molecular characterization of bacterial communities involved in the Toscano cigar fermentation. Design, management and execution of research projects particularly in the field of molecular biology and microbiology.
 

Ricercatore

At Fiuotecnica srl

From 2002 to October 2003
Design, management and execution of research projects Micro and macro arrays fabrication and hybridization for Gene Expression and for SNPs identification. Molecular diagnostic by MALDI TOF DNA sequencing Lab automation

Skills

 
  • GMP
  • HACCP
  • Intuitive and critical thinking
  • Problem solving
  • Project management
  • Quality
  • Quality Assurance
  • Quality Auditing

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