Mariangela Di Sotto

Experience

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  Janssen-Cilag

  Mar 2012 - May 2013

  Laboratory Analyst

  Quality control analyst in half finished goods/ finished goods.- Responsible to analyze pharmaceutical products using various techniques: HPLC, GC, UV-VIS, IR, Dissolution test, Particle size test.-Good knowledge of GMP and lean six sigma theory-Creation of Custom field and print report on Empower 3.- Use of specific software: Empower 1 and 3, Omnic, Qpace, eLIMS, SAP, Trackwise.

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  Pfizer

  May 2013 - May 2015

  Analytical start up expert

  -Validation and transfer of analytical methods for launch of new finished products and for optimization of the analytical methods used in QC laboratory;-Analytical transfer with the collaboration of foreign guests;-Analytical support through writing validation protocols and reports, technical documentation (in English language) and release specification;-Involved in Change Control impact assessment relevant to Analytical development and Quality Control activities ( TrackWise System);-Management of stability studies (creation of stability protocols in LIMS), management of climatic rooms in according to GMP;-Revision of development protocols and registration dossier (in collaboration with Technology and regulatory department)-Management of Deviations for improved compliance;- Revision of raw data;-Carried out release and stability analysis using the following techniques: High Performance Liquid Chromatography (HPLC), Ultra Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Inductively Coupled Plasma Optical Emission spectroscopy (ICP-OES), - Good knowledge of chromatography data software Empower, laboratory information management systems (LIMS), Quality Tracking System (QTS), Pfizer Document Control System (PDOCS), J D. Edwards (JDE). Mostrar menos

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  AIFA Agenzia Italiana del farmaco

  May 2015 - Jan 2015

  Stage Regulatory Affairs

  Internship in the European Assessment Office. Training as quality assessor (Module I,II, III CTD)• Review of module 3 of eCTD: both drug substance and drug product parties included in centralised procedures.

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  Recordati S.p.A.

  Sept 2015 - Jan 2020

  CMC Regulatory Affairs Specialist (APIs)

  - Writing and preparation of the Active Substance Master Files bothparties: i.e. applicant and restricted part for EU and Drug master files for the following markets: USA (Type 2 DMF), Japan, Brazil and Canada in eCTD; (Module 1: Letters of Access, Annex 3; Module 2 and 3).- Prepare additional information or responses as requested by regulatoryagencies (responses to deficiency letters) or by customers;- New Application or renewal/revision for the Certificate of Suitability (CEP) to EDQM;-Writing and preparation of risk assessments on elemental impurities according to ICH Q3D,- Dealt with National, Decentralised,Mutual Recognition and centralised procedures;- Handling changes and variations: Type 1A, 1AIN, Type 1B and type 2;- Good knowledge of eCTD Manager software and Veeva Vault documents management platform;- Review of all assigned regulatory submissions/MAAs for accuracy, completeness and compliance with EU regulations and relevant guidelines; ensure that all additional specific country nationalrequirements are met;-Review, give opinion (re. registration requirements) and track the change control internal process;- Escort government and customers inspectors during inspections; providepost-inspection follow-up information as requested;-Support to quality assurance department: i.e issuing and updating of SOP and general procedures; issuing of Annual Product Review (APR), preparing process validations, updating of master batch records,- Handling POL payments on AIFA website,- Very good knowledge of ICH and EMA guidelines. Mostrar menos

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  S4BT - Solutions for Business & Technology

  Jan 2020 - Feb 2023

  OTC LCM Project Manager- consultant
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  Kenvue

  Feb 2023 - now

  EMEA Dual Source Project Manager