Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Analyst QA - External Quality - Small Molecules

  • Jul 2020 - Present

  Activities :• QA release.• Preparation and management of batch documentation for QA and QP release. • Preparation of Inspection Plans in SAP.• Writing and review of Certificate of Analysis (CoA).• Site Key user eLims system. • Batch Data analysis entry and review in eLims.• Master data update and approval in eLims.• Request for Master data update and approval in SAP.• Support and point of contact for different requests in SAP and eLims systems.• Involved in the implementation of master data for new product launches.• Update of the batch release tracker.• Interface with other departments and functions (Operations, Planning, Technical Operations, etc) for support of External Quality.• Creation, monitoring of changes and quality events in Trackwise Systems :• SAP E2• eLims• Trackwise Show less

• Ingénieur Assurance Qualité

  • Apr 2019 - Jun 2020

  Activités :• Participation à l'intégration d'Actelion au sein de Johnson&Johnson.• Tri et Migration des documents Qualité (SOPs, Working Instructions, Policies , Template et Forms) de Quatro à Tru Vault.• Migration des CAPAs, Changes Control et Déviations ouverts dans Quatro vers TrackWise.• Calcul hebdomadaire des KPI liés aux activités de migration.• Mise à jour des plannings et fichiers de suivis de migration.• Contact et support quotidien auprès des équipes des départements impliqués.Systèmes :• Quatro• Tru Vault• TrackWise Show less



Pierre Fabre Group

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QiRVI Quality Assurance Officer

  • Feb 2018 - Aug 2018

  Activities : • Mapping of all quality documents of vigilance. • Calculation of the compliance indicator of submissions of periodic safety reports of pharmacovigilance (PSUR/DSUR). • Quality control of pharmacovigilance cases. • Participation in the coordination of pharmacovigilance audits. System: • My Qumas • VP2T (Vigilances Planning and Tracking Tool) • Argus Activities : • Mapping of all quality documents of vigilance. • Calculation of the compliance indicator of submissions of periodic safety reports of pharmacovigilance (PSUR/DSUR). • Quality control of pharmacovigilance cases. • Participation in the coordination of pharmacovigilance audits. System: • My Qumas • VP2T (Vigilances Planning and Tracking Tool) • Argus



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Assistant Engineer

  • Dec 2014 - Jan 2015

  Study of lysozyme degradation under shear stress for extrapolation to proteins of pharmaceutical interest. Study of lysozyme degradation under shear stress for extrapolation to proteins of pharmaceutical interest.



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Assistant Engineer

  • Jun 2014 - Jul 2014

  Study of sterilizing filtration and determination of the flow rate of different filters in order to apply a viable mathematical model for parenteral drug production. Study of sterilizing filtration and determination of the flow rate of different filters in order to apply a viable mathematical model for parenteral drug production.