Syrine Trabelsi
Cluses
Profil professionnel
Quality Assurance Engineer with experience in medical device and biopharmaceutical environments, contributing to quality strategy, process improvement, and cross-functional quality coordination in regulated R&D and manufacturing settings. Strong exposure to quality systems, supplier oversight, audit readiness, training, and continuous improvement, with a proactive and quality-driven mindset.
Vue d'ensemble
4
4
years of professional experience
4
4
years of post-secondary education
Expérience
Quality Assurance Engineer
Nextkidney SA
Lausanne
2022.11 - Current
- Acted as QA focal point and informal quality lead, supervising one team member and coordinating cross-functional quality activities across Procurement, Supply Chain, R&D, and Manufacturing.
- Oversaw day-to-day quality activities across internal operations and external manufacturing partners (CMOs), managing deviations, nonconformances (NCs), and CAPAs related to production and incoming material quality.
- Managed and continuously improved the ISO 13485-compliant Quality Management System (QMS), redesigning SOPs, work instructions, templates, and forms to transform generic consultant documentation into fit-for-purpose operational quality processes.
- Qualified, audited, and monitored suppliers and CMOs, establishing Quality Agreements, defining inspection criteria, and monitoring supplier performance.
- Prepared and supported internal, external, and supplier audit activities, contributing to 3 successful external audits and 4 internal audits, including 2 independently conducted internal audits.
- Supported clinical-stage release activities in an R&D medical device environment, ensuring compliance with product specifications, quality documentation, and applicable QMS requirements.
- Supported Management Reviews through KPI monitoring, reporting, data analysis, and action tracking.
- Led company-wide QMS training activities, training of employees on CAPA, supplier quality, purchasing controls, nonconformances, document control, and training management through classroom sessions, quizzes, and Read & Understand (R&U) activities.
Quality Assurance Intern
OM Pharma
Meyrin
2022.03 - 2022.09
- Supported quality oversight of on-site biopharmaceutical manufacturing activities, ensuring compliance of manufactured products with specifications, procedures, and quality requirements.
- Contributed to the follow-up of CAPAs, deviations, and Out-of-Specification (OOS) events in support of GMP quality processes, participating in investigations, root cause analysis, and implementation of corrective and preventive actions.
- Ensured proper traceability and documentation of quality events in TrackWise, supporting data integrity and quality record management.
- Updated quality documentation and controlled documents to support GMP compliance and process consistency.
- Participated in Gemba walks on the manufacturing floor to support process observation, quality oversight, and continuous improvement activities.
- Trained team members on investigation standards and quality procedures to support consistency in quality investigations.
Formation
Master's degree - Drug Sciences
ISPB - Université Claude Bernard Lyon 1
Lyon 2021.09 - 2022.09
1st year of Master's degree - Biochemistry & Molecular Biology
Université Claude Bernard Lyon 1
Lyon 2020.09 - 2021.06
Bachelor's degree - Biochemistry
Université Claude Bernard Lyon 1
Lyon 2017.09 - 2020.06
Compétences
- Cross-Functional Collaboration
- Quality assurance strategy
- Organization & Prioritization
- Problem Solving Thinking
- Communication & Stakeholder Coordination
- Continuous Improvement Mindset
Language
French
NATIVE LANGUAGE
English
Fluent
German
Basic knowledge
Tools
- Sharepoint
- Microsoft Office
- Notion
- Jira
- Polarion
Chronologie
Quality Assurance Engineer
Nextkidney SA
2022.11 - Current
Quality Assurance Intern
OM Pharma
2022.03 - 2022.09
Master's degree - Drug Sciences
ISPB - Université Claude Bernard Lyon 1
2021.09 - 2022.09
1st year of Master's degree - Biochemistry & Molecular Biology
Université Claude Bernard Lyon 1
2020.09 - 2021.06
Bachelor's degree - Biochemistry
Université Claude Bernard Lyon 1
2017.09 - 2020.06