Alessia Bertini

Experience

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  Farmacia Comunale n°2

  Apr 2015 - Nov 2015

  Pharmacist

  • Knowledge implementation about pharmacy management and attention to the patient• Production of galenic preparations following GLP• Organisation of the pharmacy stock and product inventory

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  Università di Pisa

  Apr 2016 - Jan 2017

  Synthetic Organic Chemist, Thesis Internship

  Thesis: Progettazione, sintesi e valutazione biologica di nuovi stabilizzatori del tetramero della Transtiretina. (Design, synthesis and biological evaluation of new Transthyretin tetramer stabilizers)Supervisors: Prof.ssa Elisabetta Orlandini, Dott.ssa Susanna Nencetti. Thesis internship done in a pharmaceutical chemistry laboratory where• I learned how to design and synthesize new bioactive compounds• I improved my knowledge of various purification techniques as well as HPLC, LPLC, GC, TLC• I improved my skills in various spectroscopy techniques such as 1H-NMR, 13C-NMR and UV-vis. Show less

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  Le Antiche Mura S.r.l.

  Jul 2017 - Jan 2019

  • Stability study of cosmetic products• Control of finished products and raw materials quality• Evaluation of all the raw materials MSDSs, statements and certifications• Support for regolatory inspection• Communication with Inspection, Control and Certification Bodies for personal-care products obtained in organic and eco-friendly production• Research and development of new natural and biological cosmetics• Complaints management I helped my colleague of Research & Development department to create new cosmetic formulations. I analyzed those formulations with tests of stability during the time and under different conditions. I began to assure the quality of the cosmetics made by the production department.

  • Quality Assurance Specialist

    Feb 2018 - Jan 2019

  • Quality Control Intern

    Jul 2017 - Jan 2018
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  Università degli Studi di Siena

  Mar 2019 - Oct 2019

  Medicinal Chemist

  Supervisor : Prof. Maurizio Botta.• Development, synthesis and purification of organic compounds• Compounds characterization through 1H-NMR• Compounds characterization through 13C-NMR• Compounds characterization through Mass Spectrometry

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  Pharma D&S

  Nov 2019 - now

  • Development and revision of:- Standard Operating Procedure (SOP)- Product Quality Review (PQR)- Quality Technical Agreement (QTA)• Development and implementation, according to ICH Q9, of Risk Assessments related to:- Potential Nitrosamines impurities contamination- Cross Contamination- Environmental contamination- Instrument calibration and equipment maintenance- Temperature excursion- Supplier evaluation- Process Control Strategy• Evaluation of supplier Audit CAPA plan• Management of follow-up activities for internal and external Audits (GMP and GVP)• Management of supplier items, audits, non-conformities, CAPAs, Immediate Actions and Changes• Complaints management• Management of Quality Agreement• Definition, monitoring and analysis of quality metrics• Definition, monitoring and analysis of KPIs• Monitoring of drug product returns• Drug products logistic release• Training on GMP and Quality Assurance requirements and systems Show less

  • Quality & Process Senior Consultant

    Nov 2021 - now

  • Quality & Process Consultant

    Nov 2019 - Oct 2021