ROUEN
Natural sciences degree, in chemistry, focused on organic chemistry, and analytics. Any professional experience in Cosmetic and Pharmaceutical business, Regulatory Affairs under cGMP/cGLP, EU GMP, ISO regulated environment. I have the proven capacity as regulatory affairs manager for submission DMF, SMF to various regulatory authorities, as laboratory Engineer within Quality Assurance & Quality Control for various systems. By that I mean, I am highly adaptable, due to my capacity to learn quickly. Also, I like facing challenges and don’t shy away from adversity. The through line of my professional career is continuous improvement in regulatory activities.
Specialties
- Regulatory Affairs / Quality Systems / Quality Assurance
- R&D/ Manufacturing
- Quality Control / Analytical Development
- Intellectual Property Industrial
- Equipment & Facilities Qualification
- Cleaning & Process Validation
- Internal Auditing Programs
- Suppliers Evaluation
- Technical Assessment
http://www.linkedin.com/in/rebeccabolognini
Mes compétences :
R&D
Chimie analytique
Qualité
Gestion de projet
Galénique
Industrie pharmaceutique
