Summary
Overview
Work History
Education
Skills
Languages
Consent
Timeline
Generic
Emanuela Ippoliti

Emanuela Ippoliti

Cisterna di Latina

Summary

Experienced professional in Quality Assurance with proven skills with Regulatory Compliance issues. Excellent team player with expertise in delivering great coaching sessions to new employee. Effectively prioritises and manages multiple projects.

Overview

15
15
years of professional experience

Work History

Global QA and Compliance

Abbott S.r.l
07.2018 - Current
  • Processing Divisional Quality System documentation (SOP, Guideline, Working Instructions) and Product- related in EDMS (Electronic Document Management System) to ensure the Data Integrity and Change Control requirements.
  • EDMS ownership to ensure implementation of all elements of the Good Documentation practice, as documentation Periodic Review (monitoring KPI), Storage of Documents, Control of Documents in GMP Areas (Controlled Copies and reconciliation).
  • Training on the EDMS (remote and on-site), perform Business Software validation (Review URS and FRS, complete and perform UAT for new releases).
  • Support of Internal/External Audits, pharma and medical device (ISO13485)

Global Change Control and Documentation

Abbott S.r.l.
01.2012 - 06.2018
  • Coordination of MoC (Management of Change) using TrackWise; collaborated with cross-functional teams to ensure smooth implementation of changes.
  • Implementation of approved regulatory notification on Quality global documentation (creation/update of specifications, test methods and manufacturing documents) to ensure global Regulatory Compliance.
  • Support in the CAPA process activities (initiate Exception Reports in case of Non-conformity and planned Deviations)
  • Processing of technical documents in the EDMS such as QTA, Stability data report, Validation reports and product quality documents to be provided to global TPMs.
  • EDMS Divisional Business Administrator.

QA/GMP Regulatory Compliance

Abbott S.r.l. - AbbVie S.r.l.
02.2010 - 12.2012
  • Site Quality documentation management: update specifications, analytical procedures and master batch records in alignment with divisional documents.
  • Gap analysis in the Quality Manufacturing Documentation versus cGMP, filed dossiers and applicable Directives & Guidelines (ICH, FDA, EP, USP).
  • Support to Quality and Regulatory functions on quality data documentation as consequence of Regulatory Variations and providing technical advice in case of Deficiency Letters.
  • Support to Regulatory Affairs in case of renewal, new submission and revision of the pharmaceutical finished products filing by preparation of CTD sections, and management of practices and certifications (e.g. CPP).

Education

Master Degree - Pharmaceutical Biotechnology

University of Rome "Sapienza"
Rome, RM
11.2009

Skills

  • Change Control management
  • Regulatory Compliance Module 3 CTD
  • Software Quality Assurance/Validation
  • Data Integrity
  • Training
  • Digital Skills: Word, Power Point, Excel, Visio (Office Suite), Adobe Professional, Adobe Captivate, TrackWise, Documentum
  • Excellent interpersonal and social skills

Languages

English
Advanced (C1)

Consent

I authorize the processing of the personal data contained in my curriculum vitae in accordance with Article 13 of Legislative Decree 196/2003 and Article 13 of EU Regulation 2016/679 on the protection of individuals with regard to the processing of personal data.

Timeline

Global QA and Compliance

Abbott S.r.l
07.2018 - Current

Global Change Control and Documentation

Abbott S.r.l.
01.2012 - 06.2018

QA/GMP Regulatory Compliance

Abbott S.r.l. - AbbVie S.r.l.
02.2010 - 12.2012

Master Degree - Pharmaceutical Biotechnology

University of Rome "Sapienza"

Similar Profiles

CREATE PROFILE
Emanuela Ippoliti