I'm a pharmacist graduated from Universidad Santa María, marketing specialist at the Central University of Venezuela and Quality Assurance specialty at the Central University. I have experience in the area of quality assurance, management and implementation of the BPD of the pharmaceutical industry, validation and audit processes. I have been responsible for managing personnel in manufacturing plant processes and in pharmaceutical products warehouses. My extensive experience in Quality Assurance and marketing, has given me an overall knowledge of the business, directly applicable to your interest Providing Third Party Audit Manager, of key contractors and suppliers. For assuring that the products supplied to our patients are manufactured, tested in accordance with c-GMPs, the registration file and any additional country specific requirements. I account with the knowledge to operate as spokesperson and developing relationships, independently negotiating. I have experienced in biopharmaceutical manufacturing and quality audit/inspections, I have experience in technical and practical knowledge of a variety of dosage forms is preferred (e.g. oral solid dosage, API) . I have received MSQA audits for 6 years and I know the system Also I have experienced in the quality/operational systems that support contractor and supplier audits and quality supply chain management. I can interpret, applying regulations, regulatory guidance, and Pfizer expectations. I have a good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations and in-depth knowledge of cGMP regulations trends and expectations and familiar with other GXP concepts and global regulations (FDA, EU)

Highlights:

• Manufacturing
• Quality
• Distribution
• Packaging
• Regulatory Affairs
• Pharmaceutical
• Supply Chain
• Oncology
• Sales
• Management