Valentina Sciancalepore

Documentation Specialist at Grünenthal Italia
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Contact Information
us****@****om
(386) 825-5501
Location
Parabiago, Lombardy, Italy, IT
Languages
  • Italiano Native or bilingual proficiency
  • Inglese Professional working proficiency
Skills

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Bio

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Credentials

  • Corso online per Auditor interno sulla Norma UNI EN ISO 9001:2015
    Area ISO S.r.l.
    Dec, 2022
    - Oct, 2024
  • Formazione generale dei lavoratori
    Assolombarda Servizi
    Nov, 2017
    - Oct, 2024
  • Attestato consulente progettista privacy
    UNINFORM GROUP
    Apr, 2017
    - Oct, 2024
  • Attestato consulente progettista sistemi di gestione della salute e sicurezza nei luoghi di lavoro (Qualità del Lavoro)
    UNINFORM GROUP
    Apr, 2017
    - Oct, 2024
  • Attestato progettista e valutatore nel modello gestionale D.lgs. n. 231/2001 e Basilea 2
    UNINFORM GROUP
    Apr, 2017
    - Oct, 2024
  • Attestato valutatore sistemista sa 8000
    UNINFORM GROUP
    Apr, 2017
    - Oct, 2024
  • Attestato verifica legislativa ambientale e gestione dei rifiuti
    UNINFORM GROUP
    Apr, 2017
    - Oct, 2024
  • Attestato Master Quality
    UNINFORM GROUP
    Mar, 2017
    - Oct, 2024
  • Attestato Progettista e Valutatore Sistemi Qualità
    UNINFORM GROUP
    Mar, 2017
    - Oct, 2024
  • Attestato corso ANGQ per auditor/responsabili gruppo di audit di sistemi di gestione per la qualità qualificato Cepas
    CEPAS
    Mar, 2017
    - Oct, 2024
  • Attestato progettista e valutatore sistemi ambiente
    UNINFORM GROUP
    Mar, 2017
    - Oct, 2024
  • Master in English Language, First Examination
    British Institutes
    Feb, 2006
    - Oct, 2024
  • English diploma level B1
    British Institutes
    May, 2005
    - Oct, 2024

Experience

  • Grünenthal Italia
    • Italy
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Documentation Specialist
      • Mar 2020 - Present

      DEVIATIONS: investigation skill, knowledge of packaging processes, deviation reports writing, compliance with deadlines. INVESTIGATION SUPPORT FOR COMPLAINS: knowledge of packaging processes; collection and processing of information; investigation skill; compliance with deadlines. BATCH RECORD REVIEW: knowledge of documentations flow, GMP compliance, knowledge of packaging process, interaction with supervisors and packaging personnel, logbooks review, compliance with deadlines, planning. LOGBOOK REVIEW: GMP compliance, planning, compliance with deadlines. TRAINER: communication, organization, development of concepts, knowledge of document flow. Show less

  • Sanofi
    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Manufacturing Compliance (Altran s.p.a. Consultant)
      • Dec 2019 - Mar 2020

      BATCH RECORD REVIEW SUPPORT: knowledge of manufacturing sterile process; knowledge of documentations; interaction with supervisors and operators; compliance with deadlines, planning. BATCH RECORD REVIEW SUPPORT: knowledge of manufacturing sterile process; knowledge of documentations; interaction with supervisors and operators; compliance with deadlines, planning.

  • Teva Pharmaceuticals
    • Israel
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Pharmaceutical Quality Assurance (Altran s.p.a. Consultant)
      • Oct 2018 - Aug 2019

      DEVIATIONS AND COMPLAINTS SUPPORT: knowledge of manufacturing sterile process; collection and processing of information; investigation skill; compliance with deadlines; deviation reports writing. DEVIATIONS AND COMPLAINTS SUPPORT: knowledge of manufacturing sterile process; collection and processing of information; investigation skill; compliance with deadlines; deviation reports writing.

    • Quality Assurance Product Support
      • Oct 2017 - Oct 2018

      BATCH RECORD REVIEW: knowledge of manufacturing documentations, GMP compliance, knowledge of manufacturing process, interaction with supervisors and operators, use of Phenix software, logbooks review, compliance with deadlines, planning. PQR: use of software like SAP, LIMS, Luna, Phenix, Word Office, Excell Office; knowledge of manufacturing processes; deviations, CAPA, Change Control, complaints analyses; Batch Record review. DEVIATIONS: investigation skill, knowledge of manufacturing processes, deviation reports writing, compliance with deadlines. WHAREHOUSE DEPARTMENT QUALITY ASSURANCE SUPERVISOR: department weekly meeting, supervision of temperature and humidity documentations of warehouse department, logbook review and deviations. BATCH RECORD ARCHIVING: use of Phenix software, deviations analyses, use of Access Office software. LOGBOOKS REVIEW: GMP compliance, planning, compliance with deadlines. Show less

  • Clinical Pathology and Microbiological Lab
    • Laboratory Biologist for Clinical and Microbiological Pathology - Volunteer Tycinology
      • Apr 2016 - Jan 2017

      Where have been learned MICROBIOLOGY: culture tests (vaginal swabs, rectal, urethral, oropharyngeal, spermiocolture, sputum, blood cultures, skin swabs, stool cultures, urine cultures), parasitological stool analysis, urinary sediment reading light microscopy, preparation of fresh slides and staining Gram, reading Scotch test, bacterial identification and antibiotic susceptibility by antibiogram, Mycoplasma research with identification and susceptibility testing gallery, calprotectin (ELISA). VIROLOGY: indirect research of specific antibodies against viral antigens that cause hepatitis A (HAV), B (HBV), C (HCV) and HIV. CLINICAL BIOCHEMISTRY: spectrophotometric assay of serum. Serum and urine protein electrophoresis is agarose gel capillary system. HAEMATOLOGY, COAGULATION AND TOXICOLOGY: blood count and coagulation; peripheral blood smears; spectrophotometric analysis of urine and serum toxicological samples. IMMUNOMETRY WITH CHEMILUMINESCENCE SYSTEM: hormone dosing and tumor markers. AUTOIMMUNITY: antibodies AMA (anti-mitochondrial antibodies), ASMA (anti-smooth muscle antibodies), EMA (anti-endomysium antibodies), LKM (anti-liver and kidney microsomal antibodies), APCA (anti-gastric parietal cell antibodies ) with methodical IFI ALLERGY: dosage of food allergens and inhalant. Show less

  • Dott. Gianmarino Consulting Room of Nutrition
    • Biologist Nutritionist - Volunteer Internship
      • Mar 2015 - Nov 2016

      Carried out at Dr. Stefania Giammarino’s private study of Nutrition in Roma Road 158, Molfetta (BA) where I learned to create personalized diets, anthropometric measurements, vision and interpretation of clinical analysis. Carried out at Dr. Stefania Giammarino’s private study of Nutrition in Roma Road 158, Molfetta (BA) where I learned to create personalized diets, anthropometric measurements, vision and interpretation of clinical analysis.

  • Coop Alleanza 3.0
    • Retail Groceries
    • 100 - 200 Employee
    • Nutrition Educator
      • Apr 2016 - Apr 2016

      Where topics such as principles of human nutrition have been treated; unhealthy diet; traceability of products; vegetarian and vegan diet. Where topics such as principles of human nutrition have been treated; unhealthy diet; traceability of products; vegetarian and vegan diet.

  • Scuola materna Filippetto e Tenente Losito
    • Nutrition Educator
      • Nov 2015 - Apr 2016

      In a playful way were discussed issues concerning the healthy diet. In a playful way were discussed issues concerning the healthy diet.

  • i Murgini
    • Farming
    • 1 - 100 Employee
    • Quality Control
      • Sep 2015 - Mar 2016

      Where I was involved in the creation of labels; traceability of products through the Lots study; creating HACCP protocol. Where I was involved in the creation of labels; traceability of products through the Lots study; creating HACCP protocol.

  • Università degli Studi di Bari
    • Italy
    • Research Services
    • 700 & Above Employee
    • Tirocinante presso il Labaoratorio di Biochimica e Biologia Molecolare UNIBA
      • Nov 2013 - Nov 2014

      Per 12 mesi ho condotto studi di sperimentazione su un organismo modello chiamato C.Elegans, in particolare sull'espressione della proteina FAD-sintasi. Ho conseguito il grado di laurea con tesi in Biochima e Biologia Molecolare dal titolo “EFFETTI DEL SILENZIAMENTO DEL GENE flad-1 SULLA TRASMISSIONE NEUROMUSCOLARE IN C. Elegans”. Sono state acquisite competenze nell'utilizzo di strumentazioni di laboratorio base, preparazione di terreni di coltura per nematodi C.elegans, spettrofotometro, pH-metro, autoclave, colture batteriche solide e liquide, microscopio. Show less

Education

  • Uninform Group
    Master Quality - Experts in business management systems - quality, safety, energy, Tecnologie/tecnici del controllo qualità e sicurezza
    2017 - 2017
  • University of Bari “Aldo Moro”
    Master's Degree in Biology, Scienze Biosanitarie
    2012 - 2014
  • American & British Academy - ABA English
    Advanced B2 - C1, English
    2015 - 2016

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