Greater Turin Metropolitan Area
Mi ritengo una persona socievole, curiosa e positiva. Mi piacciono le sfide e approcciarmi ai problemi analizzandoli da diversi punti di vista, avendo svolto una formazione eclettica e interdisciplinare. Per questo motivo sono sempre interessato ad acquisire sempre conoscenze teoriche e competenze pratiche. Sono fortemente motivato e orientato al conseguimento di risultati sia aziendali che personali. Alla passione per le scienze (soprattutto la biologia e la chimica) associo uno spiccato interesse per la cosidetta cultura "nerd": adoro infatti il mondo videoludico, l'animazione giapponese e i film.
As a Quality Assurance Process & Cleaning Validation Speciliast for PDS department, I ensure compliance and excellence in process and cleaning validation while supporting manufacturing, quality, and regulatory teams. I combine technical expertise with cross-functional collaboration to strengthen compliance, streamline processes, and enable successful regulatory submissions. Key Focus Areas: Driving compliance of manufacturing and cleaning validation strategies with company SOPs and global regulatory standards. Supporting manufacturing teams in deviation management, validation impact assessment, and process performance qualification (PPQ) batches. Defining validation strategies within change control and providing expert quality input. Reviewing and optimizing documentation for process validation, tech transfer, and cleaning validation to ensure inspection readiness. Preparing and reviewing quality risk assessments, including cross-contamination studies, to mitigate risks and ensure patient safety. Partnering with regulatory teams to review CTD sections (e.g., 3.2.P.3) and strengthen dossier submissions.
- Prepare the technical documentation for process and cleaning validation activities (Validation protocol/Report, Technical document, FMEA, Validation Master Plan) - Ensure the correct execution of the activity through the coordination and the supervision of the function involved (Production, QC depts.) in compliance with protocols, SOPs and global guidelines. - Define the validation strategy and sampling plan in cooperation with the clients -Support Project Management and Quality Operation units during the management of project time line, Change Control and deviations and support Team Leader during Audit as Process & Cleaning Validation SME
- Preparation of the first local site Periodic Validation Review, a dedicated technical report aimed at verifying the validation package adequacy (stage 2) and its adherence with Process Design documentation (stage 1) and LSOP - Preparation of Process Validation Protocol and Report
Working in a CDMO leader for protein hydrolysate market, my main duties were: - Design and execute lab-scale tests of enzymatic hydrolysis on raw - Execute test for characterization and release on protein hydrolysate prototypes - Statistical analysis of results - Support other functions such as QA, QC and Production
Execution of lab-scale tests for metal nanoparticles synthesis through electrocatalysis and preparation of periodic reports (AquiRem project)
- Chemical synthesis of functional monomer and polymerization - monomers structure characterization - Lab-test for the characterization of polymer's binding properties through solid-phase extraction column - Lab techniques explored: Spectrophotometry UV-Vis, Mass spectrometry, HPLC-MS