Basic

Dr. Luigi De Rosa

Employee, Associate Director, Sterile Manufacturing External Quality Assurance, MSD Sharp & Dohme GmbH

Lucerne, Switzerland

Skills

Quality Management
Quality Assurance
Pharmaceutical industry
Pharmacy
Six Sigma
quality assurance
Produktion
GMP

Timeline

Professional experience for Luigi De Rosa

  • Current 3 years and 5 months, since Feb 2018

    Associate Director, Sterile Manufacturing External Quality Assurance

    MSD Sharp & Dohme GmbH

    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.

  • 1 year and 10 months, Apr 2016 - Jan 2018

    CMO Quality Manager API

    GSK Consumer Healthcare

    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.

  • 1 year and 7 months, Sep 2014 - Mar 2016

    Senior Quality Assurance Associate

    Aspen Global Incorporated

    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.).

  • 1 year and 8 months, Jan 2013 - Aug 2014

    Quality Assurance Specialist TPO Europe

    Novartis OTC

    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.

  • 1 year and 2 months, Nov 2011 - Dec 2012

    Quality Assurance

    DSM

    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.

  • 5 years and 8 months, Mar 2006 - Oct 2011

    Quality Management Consultant

    Associazione dei Professionisti della Qualità

    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.

  • 1 year and 7 months, Jun 2004 - Dec 2005

    Researcher

    British American Tobacco

    • 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.

  • 1 year and 1 month, Oct 2002 - Oct 2003

    Ricercatore

    Fiuotecnica

    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).

Educational background for Luigi De Rosa

  • 2005 - 2006

    Biotechnology

    Università di Napoli "Federico II"

    Molecular and Industrial Biotechnologies

  • 1996 - 2002

    Biotechnologies

    Università di Napoli "Federico II"

    Industrial Biotechnologies

Languages

  • English

    Fluent

  • Italian

    First language

  • French

    Intermediate

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