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
12.2023 - 06.2024
- 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
07.2022 - 06.2023
- 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
10.2021 - 06.2022
- 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
02.2018 - 02.2021
- 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
07.2013 - 07.2014
- 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
09.2016 - 06.2017
MSc - Bio-engineering Life Sciences and Technologies
09.2011 - 06.2013
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»
12.2023 - 06.2024
QA CSV Validation
Ordina
07.2022 - 06.2023
QC Microbiology Validation Officer
Catalent Pharma Solutions
10.2021 - 06.2022
QC Microbiology, Process Utilities, and Validation
GlaxoSmithKline Vaccines (GSK)
02.2018 - 02.2021
University certificate - Food flavors and innovation
Agro-Bio Tech
09.2016 - 06.2017
QC engineer
Vitalait
07.2013 - 07.2014
MSc - Bio-engineering Life Sciences and Technologies
09.2011 - 06.2013
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