Freelancer profile translated to English.
Back to original languageAbout Emira
Quality assurance consultant in the pharmaceutical industry. Specializing in R&D, I master various regulatory scopes: GCP, GLP, GCLP, Clinical GMP....
I can also provide my skills as a Trainer and Auditor.
French
Native or bilingual
English
Fluent
Can work on-site
Lyon (up to 50km)
Experience
- JUVISEQA consultant ManagerPHARMACEUTICALS INDUSTRYMay 2024 - February 2025 (9 months)Lyon, FranceOperating Site Scope - GMP/GSP/GDP/Promotional Activities (CSO)1-Quality Assurance Activity:–Quality management system: audit planning, subcontractor management (Manufacturers/Distributors/CSO/PV subcontractors), document management, audit report review, preparation and management of Self-Inspections, Data Integrity, IT projects (system migration/upgrades)–Operational Quality Assurance: APR, quality events, questionnaires, CAPA plan2-Registration of subcontractor sites (CMO) internationally (preparation of documentation for local regulatory authorities)
- ABEM CONSEILQA consultant Manager & AUDITORPHARMACEUTICALS INDUSTRYMarch 2024 - Today (2 years and 5 months)- CRO QA Manager: GDPR, GCP- Auditor: ISO9001, archiving sites, GDP, GCP, GLP,...- GLP expert- CMO sites registration (LATAM, GCC, MEA,...)
- IndépendantIndependent Quality Engineer ConsultantPHARMACEUTICALS INDUSTRYMarch 2024 - Today (2 years and 5 months)Lyon, France
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Education
- Master 2 (M2), Engineering for Health and Medicine (from clinical evaluation to Quality)Institut de Pharmacie Industrielle de Lyon - IPIL2012Master 2 (M2), Ingénierie pour la Santé et le Médicament (de l'évaluation clinique à la Qualité)
- Management Training course, Marketing/Marketing Management, Generalemlyon business school2012Management Training course, Marketing/Marketing Management, General