Vue d'ensemble
Expérience
Formation
Compétences
Langues
Chronologie
Generic

Helmi Zitouni

QA/QC Specialist

Vue d'ensemble

11
11
years of professional experience
2
2
years of post-secondary education

Expérience

Data Integrity Specialist PS Portfolio Management

Consultys Benelux «Vulcain»
Braine-l'Alleud
2023.12 - 2024.06
  • Perform Data Integrity check for DoxTM submission
  • Lead meeting with DI checkers and external partners CMO
  • Follow-up on documentation updates with CMO
  • Follow-up on progress review and correction implementation
  • Writing of report at the end of the project

QA CSV Validation

Ordina
Wavre
2022.07 - 2023.06
  • Validation CSV documentation: URS + IQOQ
  • Follow-up on validation tests
  • Document management
  • Verification of validation test conformity and regulatory compliance
  • Periodic validation documentation for a Bio-fermenter

QC Microbiology Validation Officer

Catalent Pharma Solutions
Bruxelles
2021.10 - 2022.06
  • Writing Validation Protocols/Reports for Bioburden and Endotoxin
  • Planning and coordination of microbiological tests
  • Follow-up and review of documentation, including raw data
  • Managing sample schedule
  • Improving the Quality System by creating a monthly environmental committee

QC Microbiology, Process Utilities, and Validation

GlaxoSmithKline Vaccines (GSK)
Wavre
2018.02 - 2021.02
  • Technical support for the analysis of endotoxins (LAL) and Bioburden
  • Participation in the review of SOPs during GEMBA
  • Template creation for LIMS setup
  • Effective time management and planning

QC engineer

Vitalait
Dkhila
2013.07 - 2014.07
  • Supervision of quality and hygiene, including 'traceability and HACCP'
  • Handling non-conformities and incidents
  • Personnel Training

Formation

University certificate - Food flavors and innovation

Agro-Bio Tech
2016.09 - 2017.06

MSc - Bio-engineering Life Sciences and Technologies

2011.09 - 2013.06

Compétences

  • Resilience to stress
  • Strong decision-making abilities
  • Effective communication skills

Langues

French
Opérationnel
English
Intermédiaire

Chronologie

Data Integrity Specialist PS Portfolio Management

Consultys Benelux «Vulcain»
2023.12 - 2024.06

QA CSV Validation

Ordina
2022.07 - 2023.06

QC Microbiology Validation Officer

Catalent Pharma Solutions
2021.10 - 2022.06

QC Microbiology, Process Utilities, and Validation

GlaxoSmithKline Vaccines (GSK)
2018.02 - 2021.02

University certificate - Food flavors and innovation

Agro-Bio Tech
2016.09 - 2017.06

QC engineer

Vitalait
2013.07 - 2014.07

MSc - Bio-engineering Life Sciences and Technologies

2011.09 - 2013.06
Helmi ZitouniQA/QC Specialist