Luigi De Rosa

Luigi De Rosa

API Quality Manager CMO, GlaxoSmithKline

Lausanne, Switzerland

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His background

  • Today
    2017
    April 2016

    API Quality Manager CMO

    +5000 employees

    • 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 indicators.
    • Accountable for establishing and maintaining an effective working relationship with the key contacts at each of the assigned suppliers. These include key contacts with Quality, Regulatory, Business Development, Production, Site Management and others.
    • Developing and maintaining, in partner with the Supplier Relation Manager (SRM), an effective working relationship with internal stakeholders and all members of the Supplier Relation Team.
    • Responsible for assessing the risk, identifying gaps and implementing quality action plans at assigned suppliers and communicating to the organization so the risks are proactively addressed.
    • Ensuring timely communication of Quality Alert issues. Co-ordinating and track any remediation deemed necessary.
    • Providing support to procurement throughout the supplier selection process.
    • Evaluating effectiveness of the suppliers’ Quality Unit and systems and influencing External Suppliers promoting robust systems under self-sufficient organizations.
    • Ensuring that investigations associated with assigned Suppliers are properly carried out, resulting in sustainable CAPA, documented, evaluated, and closed as efficiently as possible, and in respect with the procedure.
  • Today
    March 2016
    September 2014

    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.).
  • Today
    August 2014
    January 2013

    Quality Assurance Specialist TPO Europe

    +5000 employees

    • 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.
    • Managed all the critical quality issues (deviations, OOS/OOE, complaints, CAPA, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual, verifying the correct execution of investigations.
    • Ensured the correct management of Change requests, from receipt through to the implementation and closure.
    • Critically assessed the performance of products and processes and implemented Quality Risk Management.
    • Developed Supplier Quality Assurance Agreements.
    • Assessed and reviewed PQR/APR and Stability reports.
  • Today
    December 2012
    November 2011

    Quality Assurance

    DSM

    * 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 quality system procedures and SOPs, GMP documents, specifications and analytical methods for raw materials, finished and intermediate products.
    * Executed Self-Inspections Audits.
    * Provided active support for FDA Regulatory Inspections. Audit passed with no 483.
  • Today
    October 2011
    March 2006

    Consultant for Quality, Environment and Food Safety MS

    Associazione dei Professionisti della Qualità

    * 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 audits, implementation of product specifications and improvement plans.
    * Executed both internal and external audits of management systems for different types of companies.
    * Assured the compliance with applicable regulations and the relations with the inspection bodies.
  • Facoltà di Scienze Biotecnologiche

    Biotecnologie Molecolari e Industriali
  • Today
    2005
    2004

    Ricercatore

    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.
  • Today
    October 2003
    2002

    Ricercatore

    Fiuotecnica srl

    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
  • Biotecnologie Industriali

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His skills

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

His languages

  • Italian
    ****Mother tongue
  • English
    ****Bilingual
  • French
    *Beginner***

    About him

    • 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

    His activity on Viadeo

    Recent contacts
    Agrican Adele
    • Accounts Payable Specialist, JTI (Japan Tobacco International)
    Zaiton Sidek
    Chris SAVIGNAN
    Sabine MARCHAND

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