Dr. Massimo Trofino

Angestellt, Quality Control Manager, Ginsana SA

Bioggio, Switzerland

Skills

Lab. QC Supervision
Lab. Head
Quality Assurance specialist
Computer System Validation
Process Validation
Cleaning Validation
People Management
Controlled material management
HPLC
ICP
GC
cGMP
GLP
OOx Management
CMC
CAPA
Capacity Planning
Eudralex Vol. 4
FDA CFR 21 Part 820
FDA CFR 21 Part 11
Data Integrity
GAMP 5
Lean Six Sigma
Regulatory Affairs
Regulatory Compliance

Timeline

Professional experience for Massimo Trofino

  • Current 9 years and 8 months, since Oct 2014

    Quality Control Manager

    Ginsana SA

    I drive the management of QC analytical lab of the manufacturing site. The group is responsible for the release and stability analysis of all products manufactured on site. Moreover I collaborate with the R&D and Regulatory Affairs departments. In this role I gained considerable experience in dealing with Data Integrity issues and have an important role in the relationship with the company’s main customer Sanofi.

  • 4 years and 3 months, Jul 2010 - Sep 2014

    Lab QC supervisor

    Novartis Pharmanalytica SA

    Pharmanalytica SA is the European Stability Centre of Novartis. It is located in Locarno, Switzerland. I coordinated the activities of one of the centre’s QC analytical labs. The group was responsible for executing several important projects (e.g. Stability Commitment, Follow-up Stability Studies, Registration Stability Studies) conducted in Locarno. My responsibilities included the scheduling of activities on the basis of expected workload.

  • 2 years and 3 months, May 2008 - Jul 2010

    Qualified Person

    Nuova Farmec Srl

    Responsible for the Batch Release of medicinal products, medical devices and cosmetics manufactured in the company. Management of Quality System according to cGMP and ISO 13485.

  • 8 years and 2 months, Apr 2000 - May 2008

    Senior Scientist

    GlaxoSmithKline

    pre clinical DMPK, in vitro studies, ex-vivo studies, PK/TK modeling, chromatography, HPLC, radioactive compounds, GLP, protocol and report writing, study planning

  • 6 months, Jul 1999 - Dec 1999

    Stager

    Institute for Pharmacokinetics Studies

    Bioanalytical activity in clinical studies.

  • 11 months, May 1998 - Mar 1999

    Junior Scientist

    Istituto Mario Negri Sud

    Validation of new HPLC-UV and GC-FID methods and their application in the analysis of biological samples (study of environment and life quality).

Educational background for Massimo Trofino

  • 5 years and 6 months, Sep 1992 - Feb 1998

    Università di Bologna - Chimica e Tecnologia Farmaceutica

    Pharmaceutical chemistry

Languages

  • Italian

    First language

  • English

    Fluent

  • German

    Basic

  • French

    Basic

Interests

Reading
Bridge
Astronomy
Badminton

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