Marken, Peru
Senior Specialist in Clinical and Pharmaceutical Logistic Operations
Professional Pharmaceutical Chemistry qualified and enabled, graduated from the Faculty of Pharmacy and Biochemistry, of Universidad Nacional Mayor de San Marcos. Eight years of experience in pharmaceutical, cosmetic, food, veterinary, mass consumption and medical device industries ; with solid knowledge in Good Manufacturing Practices, Good Laboratory Practices, Good Documentary Practices, Good Storage Practices, Transport and Distribution, HACCP, Cold chain, Healthcare and Pharmaceutical Logistics, First, Second, and Third-party audits, Regulatory Affairs Management in products: Pharmaceutical (Category I, II and III), Herbal health, Natural, Dietary supplements, Galenic), Biologics and Biosimilars, Medical devices and equipment (Class I, II, III and IV), Sanitary Products (Cosmetics, sanitary articles and home hygiene products), Qualification of suppliers, Validation of manufacturing processes, cleaning and sanitizing, packaging units for refrigerated products, and analytical techniques; Ratings for critical support systems, areas and premises, equipment and machines. Additionally, I possess higher studies in Project Management, Integrated Quality Management Systems: ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, 21 CFR, ICH Q7, Q8, Q9, Q10 and International Trade.