Quality, Regulatory, and Manufacturing in Pharmaceutical Industry - Corporate Management
International Management :
- Leadership based on technical credibility, integrity, shared vision, trust and team work.
- Team & Project management: Inpulse, lead and manage changes and continuous improvements through international and multidisciplinary teams.
Quality expertise, International Regulatory and Pharmacovigilance:
- European and US cGMPs, Regulatory requirements and international standards ICH/ISO.
- Experience in Injectables products, sterile and aseptic processes, Lyophilization,
- Drugs and Medical Devices
Business oriented :
- Drive to Excellence for competitive advantages, results focused.
- Risk management: develop risk based approach through organizations, prevent and manage crisis.
- Authorities representative: QP & Responsible Pharmacist, international inspections management.
Mes compétences :
Pharmacovigilance
Qualité
Assurance qualité
GMP
MRP
Audit
FDA
Production
Bonnes Pratiques de Fabrication