About Léa
- Dermo-cosmetic studies of the project
- Preparation of the ingredient blacklist
- Research and selection of active ingredients
- Assistance with fragrance creation
- Writing a detailed creative brief
- Monitoring formulation trials
- Pre-safety assessment
- Sensory evaluation of formulation trials
- Monitoring and validation of pre-tests
- Evaluation of microbiological sensitivity and stability
- Validation of industrial pilot
- Stability study
- Safety study
- Efficacy study
- Calculation of theoretical PAO
- Actual PAO
- Product Information File (PIF)
- Safety assessment (toxicological study)
- Notification
- Validation of final artwork approval
- Certification
- Certificate of Free Sale (CFS)
- Recommendation
- Validation of batch release
- Non-conformity management
- Quality audit
- Export assistance (obtaining the certificate of conformity): Saudi Arabia, Egypt
Arabic
Native or bilingual
French
Native or bilingual
English
Fluent
Experience
- ICHC-ConsultConsultant in R&D and Regulatory AffairsFASHION AND COSMETICSDecember 2020 - Today (5 years and 6 months)Saint-Maur-des-Fossés, FranceManagement of cosmetic product development projects and subcontractor managementR&D:
- Development specifications, Active ingredient selection, Fragrance creation, Development process management, Test monitoring, ...
Regulatory Affairs:- Regulatory file (PIF), Regulatory compliance (labeling, instructions, communication materials).
- Certification: Cosmos, Halal, CFS, ...
- CPNP Notification.
Toxicology:- Safety assessment of cosmetic products.
Quality:- Quality audits of subcontractors according to ISO 22716 standard.
- Laboratoires ArcanaHead of R&D, Quality Assurance, and Regulatory AffairsFASHION AND COSMETICSSeptember 2016 - January 2020 (3 years and 4 months)Neuilly-sur-Seine, FranceManagement of product development (natural and organic):
- Specifications
- Active ingredient research
- Formulation
- Tests,
- Clinical evaluation,
- Scale-up to industrial level,
- Scientific communication dossier
Quality Assurance- Release of subcontracted batches (production and packaging)
- Non-conformity/CAPA management
- Quality audit
- Creation and development of documentation
Regulatory Affairs- Regulatory file/PIF
- Notification
- Cosmos Certification
- International Registration
- Regulatory Watch
- Sarrag PharmaHead of R&D and QualityPHARMACEUTICALS INDUSTRYFebruary 2013 - March 2015 (2 years and 2 months)Lattaquié, SyriaParticipation in the launch of a cosmetic product line.
- R&D project management: formulation, testing, and regulatory.
- Implementation of a quality assurance program in compliance with ISO 22716 and ISO 9001 standards
- Release of raw material, active ingredient, bulk, and finished product batches.
- Non-conformity management and continuous improvement
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Education
- Inter-University Diploma (DIU): Medical ToxicologyFaculty of Medicine - University of Lille2023
- Master 2: Quality of Health Products, Cosmetology trackFaculty of Pharmacy, University of Paris V2016Formulation, Règlementation, Assurance Qualité des Produits Cosmétique
Skill set (15)
Categories
- Other