Aurelio Borrero Email & Phone Number

Miami, Fl, Us

Miami, Florida

Experts on FDA/ISO Quality Systems for PHARMA and Medical Devices. Extensive experience on Product/Process Technology Transfer and ValidationsCurrently Consulting with Kimberly Clark Corporation in Houston, TX

Santo Domingo, Dominican Republic

BBRAUN Medical Corporation manufactures Class I and Class II Medical Devices and has 18/6 work week and 1500 employees. I was responsible for the planning and control of a $3 million Department Budget and management of the following areas and systems: Incoming Inspection, Process Control, Product Releases, Document Center, Calibration and Metrology Laboratory, Environmental and Microbiology Laboratory, Validations, Change Control, CAPA, Customer Complaints, Internal Audits and Supplier Program.• Direct reports: Three Section Quality Managers, one Product Release and Document Control Supervisor, one Compliance Specialist, one Microbiology Supervisor and a Quality Engineer. • Indirect Reports: 45 Quality QC Inspectors, 3 Documentation Clerks, 2 Metrology Technicians and 2 Microbiologists.

Sabana Grande, Puerto Rico

This was a 1300 employees Plant that manufactured Class I, II Medical Devices, APIs and Medicated Food and had 24/7 work week. I was responsible for the Planning and Control of a $5 million Department Budget, direct the areas of Receiving Inspection, Process Control, Product Releases, Document Center, Calibration and Metrology Laboratory, Environmental and Microbiology Laboratory, Chemistry Laboratory, Validations, Change Control, CAPA, Customer Complaints, Internal Audits and Supplier Program for compliance to 21 CFR Parts 820, 210 and 211 and ISO 13485, EPA, OSHA, UL and NSF. Responsible for hiring, training, developing and directing a staff consisting of: • Direct reports: One Process Control Manager, one Microbiologist, Metrology and Chemistry Laboratories Manager, one Quality Engineer Manager, one Regulatory Compliance Manager, one Product and Document Control Supervisor and one Administrative Assistant.• Indirect Reports: Five Process Control Supervisors, four Documentation Clerks, three Chemists, two Microbiologists, six Laboratory Technicians, two Calibration Technicians and 45 QC Inspectors

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Mba, Industrial Management