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