Claudia Guidotti

Claudia Guidotti has a diverse work experience in the pharmaceutical industry. Claudia is currently working as a Senior Consultant Quality and Validation Lead at BASE life science since April 2023. Prior to this, they worked as a Senior Pharmaceutical Consultant at m-Squared Consulting from September 2022 to April 2023.

From January 2020 to July 2022, Claudia worked at Philogen S.p.A. as a GMP QA Specialist/ GLP QA Manager/ Responsabile SGQ.

Before joining Philogen S.p.A, they worked at m-Squared - Consulting from November 2018 to January 2020 as a Pharma Senior Consultant come Quality Assurance Specialist for Chiesi Farmaceutici. Their responsibilities included managing deviations, CAPA, BR review, PQR and APR, documentation GMP, and ISO 9001:2015- GMP Improvement. Claudia also had experience in project management, technical writing, and process improvement.

Claudia also gained experience as a GMP Assistant Pharmaceutical Consultant at CTP SYSTEM from February 2017 to October 2018. Their roles included reviewing process procedures, risk analysis, protocols, and process validation reports for the production of sterile drugs. Claudia also worked on change control and deviation management and review.

In addition, Claudia worked at GSK Vaccines from February 2017 to February 2018 as a GMP Assistant Pharmaceutical Consultant in Process and Quality. Claudia was involved in writing documents and collaborating on activities related to the installation and qualification of new tools and processes for the construction of new laboratories. This included writing SOPs, work instructions, technical reports, and procedures for balances, PHmeters, isolators, autoclaves, washer, and laboratory instrumentation.

Other experiences in Claudia's career include working as a Product Expert at GSK Vaccines from May 2016 to January 2017, an AD e GMP Analyst at PATHEON ITALIA SPA from September 2015 to May 2016, a Microbiological Technician from April 2014 to November 2014, and a Chemical Analyst at Pfizer Italia from August 2012 to October 2013.

Claudia also worked as a Consulente e Formatore at CNA Ascoli Piceno e Aziende Associate CNA from February 2012 to March 2013.

Claudia Guidotti's education history is as follows:

- From 2015 to 2017, Claudia attended Università degli Studi di Siena and completed a Corso di Master Universitario di 2° livello-CMU2 in Scienze e Tecnologie Farmaceutiche, with a focus on Tecnologie farmaceutiche industriali.

- In 2019, Claudia received professional training at QGest s.r.l. Organismo di Certificazione in "Auditor/ Lead Auditor Dei Sistemi di Gestione Qualità, Ambiente, e Sicurezza dei Lavoratori".

- From 2009 to 2011, Claudia studied at Università degli studi di L'Aquila and obtained a Laurea magistrale in Biotecnologie Molecolari e Cellulari, specializing in Biotecnologie.

- From 2006 to 2009, Claudia completed a Laurea triennale in Biotecnologie at Università degli studi di L'Aquila.

- Claudia attended Liceo Scientifico from 2001 to 2006, where they received a Diploma Liceo Scientifico with a focus on materie umanistiche e scientifiche.

- Claudia also received a Six Sigma: Green Belt certification from LinkedIn in April 2020, a Risk-Based Verification of Facilities, Systems and Equipment certification from ISPE in March 2020, an FMEA certification from m-SquaredAcademy in January 2019, and a Technical Writing certification from m-SquaredAcademy in January 2019.

- In November 2013, Claudia obtained the Istruttore body building e personal trainer certification from W.F.F. N.A.B.B.A. Italy.

Additionally, Claudia is currently pursuing a degree in Biomedical Engineering at Università degli Studi Niccolò Cusano, which is expected to be completed between 2021 and 2024.