Summary
Overview
Work History
Education
Skills
Permanent Residence Card
Personal Information
Affiliations
Languages
Certification
Timeline
Generic
Susel Huerta Leon

Susel Huerta Leon

Carate Brianza

Summary

Accurate Quality Assurance Manager with 9 years of experience in the quality assurance industry in regulated environment (GXP, ISO 13485).

Adept at establishing requirements that meet quality assurance objectives and standards.

Skilled at reporting QA results and project updates to management.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Sites QA MANAGER

STERIS S.p.A.
Biassono and Poggio Rusco
10.2022 - Current
  • Management of QA team (4 QA Analysts) and daily activities of QA personnel such as setting goals, providing guidance and assigning tasks.
  • Leading and directing the activities of the team and collaborate with other departments to ensure processes follow ISO 13485 and regulatory requirements
  • Management of already existing QMS for Poggio Rusco site
  • Start Up of Biassono Site: development and implementation of a local QMS system and update the global QMS system to include the new site
  • Management of Notification body inspections and customers audits
  • Analysis, development and implementation of processes management and KPIs
  • Recruitment and evaluation of QA Personnel
  • Collaboration with corporate sites for the implementation of new DMS (TW portal for documentation)
  • Application and actively participation to the development of Lean Management, 5S and principles of Kaizen

QA Officer

Sirton Pharmaceuticals S.p.A.
Villa Guardia (Como)
12.2021 - 10.2022
  • Management of deviations, changes, CAPAs, Complaints and Customer audits follow up.
  • Procedures drawing up and implementation of modules
  • Management of Media Fill and process cleaning and validations, both for already existing department and for the new department in class A following updated annex 1 Eudralex GMP

QA Specialist

Olon S.p.A.
Segrate (MI)
02.2020 - 12.2021
  • Management and review of the quality documentation (CAPA, deviations, change control, batch records, complaints, SOP, training, Quality Agreement,etc)
  • Management of PQR and Process validation (Generic API and CDMO)
  • Management of audits( self audits, Customers, Suppliers)
  • Validation Master Plan update and Master batch records drawing up
  • KPI management
  • Use of SAP QMS system.

MSAT KPI Team Leader

Lonza Netherlands B.V.
Geleen
11.2019 - 01.2020
  • Management and review of change, deviation and CAPAs in MSAT department
  • Management of training documentation (SOP, modules, personal record card, training plan, training registration) and execution of training to operating personnel
  • Interface with corporate QA and alignment of MBRs with GMPs in the transition from the engineering design phase to manufacturing for market and/or clinical trials
  • Use of Trackwise and Documentum system.

QA Specialist

Icrom S.p.A.
Concorezzo (MB)
09.2017 - 10.2019
  • Management and review of quality documentation (CAPA, deviations, change control, logbooks, batch records, complaints, SOP, WI, training, IQ / OQ, risk assessment, cleaning, pest control, suppliers, Quality Agreements, audits, etc)
  • PQR, Process Validation (protocol and report), SOP, WI and modules drawing up and implementation
  • Drawing up and review of documentation for authorities' inspection (AIFA, FDA and PMDA), active participation during authorities' inspections and customer audits and management of follow-up documentation.

QA Specialist

Francia Farmaceutici S.r.l.
Milan (MI)
06.2017 - 09.2017
  • Management and revision of BR (approving, and reviewing, emission of a certificate of release according to Annex 16). SOP, Master Batch Record and module implementation
  • Management and review of quality documentation
  • Collaboration with RP for plant activities, for quality monitoring of production

QA Manager /QC Manager

Depo Pack snc
Saronno (VA)
01.2016 - 06.2017
  • Management and review of quality documentation
  • Setting and preparation of clinical studies' kit (batch records, creations of labels in compliance with Annex 13) and AIC documentation
  • Assisting the QP in her activities, including audits to suppliers and from authorities and customers
  • Procedures drawing up and implementation of SOP modules
  • Managing a team of 2 people
  • Check the products quality, approval or rejection of incoming goods (based on CoA and GDP)
  • Management of reference and retention samples
  • Management of the temperature monitoring and pest control system
  • Knowledge of Annex 13 (IMP), GMP and GDP.

QA Stage

Teva pharmaceuticals
Villanterio plant
05.2015 - 11.2015
  • Production Batch Record and logbooks review. Personnel training registration
  • Assistance during AIFA and FDA inspections and customer audits
  • Knowledge of ICH Guidelines and GMP.

Education

Master degree in Industrial and Management Chemistry -

University of Milan

Skills

  • Team Supervision
  • Team Building and Motivation
  • Quality Standards Determination
  • Continuous Improvement

Permanent Residence Card

True

Personal Information

  • Date of Birth: 06/25/1986
  • Gender: F
  • Nationality: Cuban
  • Driving License: B

Affiliations

  • Manga reader
  • Writer in free time
  • Mother

Languages

Spanish
First Language
Italian
Proficient (C2)
C2
English
Advanced (C1)
C1
French
Elementary (A2)
A2

Certification

  • Internal auditor certificate (BSI)
  • Lead auditor certificate (BSI)

Timeline

Sites QA MANAGER

STERIS S.p.A.
10.2022 - Current

QA Officer

Sirton Pharmaceuticals S.p.A.
12.2021 - 10.2022

QA Specialist

Olon S.p.A.
02.2020 - 12.2021

MSAT KPI Team Leader

Lonza Netherlands B.V.
11.2019 - 01.2020

QA Specialist

Icrom S.p.A.
09.2017 - 10.2019

QA Specialist

Francia Farmaceutici S.r.l.
06.2017 - 09.2017

QA Manager /QC Manager

Depo Pack snc
01.2016 - 06.2017

QA Stage

Teva pharmaceuticals
05.2015 - 11.2015

Master degree in Industrial and Management Chemistry -

University of Milan

Similar Profiles

CREATE PROFILE
Susel Huerta Leon