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Click here or scroll down to respond to this candidateCandidate's Name
Street Address North Course Drive, Apartment 902Pompano Beach, FL Street Address
Phone: (PHONE NUMBER AVAILABLE Mobile: (PHONE NUMBER AVAILABLE E-mail: EMAIL AVAILABLECURRICULUM VITAEMANAGEMENT - Managed the design, development, and implementation of quality assurance, regulatory and manufacturing functions, and procedures, such as: Supplier/CMO Auditing and Qualifications; Change Control, Investigation of Complaints and Deviations, CAPAs, Equipment / Process Validations, Facility Design and Operations, Product / Process Technical Risk Assessment Reviews, Change Review Boards and Training Systems.Managed regulatory compliance functions such as: preparation and maintenance of Drug Master Files (DMFs), New Drug Applications (NDAs), abbreviated new drug applications(ANDAs), Design History Files (DHFs)Management of drug product recalls, hosting regulatory inspections (e.g., FDA/TGA/WHO), corresponding / interacting (on behalf of clients) with FDA district and headquarters representatives as well as with various regulatory agencies.Lead, organized, and supervised manufacturing, engineering, development, and quality assurance teams during the design and construction and qualification of manufacturing facilities for Pharma and Biotech firms.TECHNICAL - Provided support, technical and regulatory compliance advice, and auditing of commercial and clinical supplies manufacturing of small and high volume sterile / non-sterile active pharmaceutical ingredients (APIs), high and low volume parenteral drugs, and a variety of dosage forms, including combination products.Assessment and oversight of technical, mechanical, and manufacturing factors related t process deviations to decide the appropriate course of action, including outsource Materials, and Supply Chain activities.Coordinated, monitored, and evaluated technology transfer activities, and process and system changes from both a quality, and process efficiency perspective for Pharma and Biotech companies, as per US-FDA and EMEA requirements.Supported engineering and process and analytical development groups in the design, implementation, and validation of equipment, manufacturing processes, laboratory test methods and computerized systems, including reviewing and approving validation protocols and reports.Provided advice to legal counsel in matters of drug, device, and diagnostic products compliance to requirements and regulatory commitments in market authorizations in the United States, Europe, Canada, and Australia.COMMUNICATIONS - Coordinated the preparation of quality systems performance and compliance reports.Developed and conducted GMP training programs.Audited commercial and clinical supplies manufacturing firms (suppliers / CMOs) and provided advice during technical and regulatory meetings with customers and providers of contract manufacturing and testing services.On behalf of clients, liaised with the FDA / EMEA / WHO / TGA and other regulatory agencies in matters of GMP and regulatory compliance.Advised and assisted in the preparation of Quality Agreements and evaluations and auditing/selection of commercial and clinical materials CMOs.Developed and implemented strategies for resolution of regulatory events such as Warning Letters and Consent Decrees for National, multinational, and foreign firms, including computer systems validation and data integrity findings.Work well independently and as a member of teams. Excellent writing, reading and organizational skills. Fluent in English and Spanish. Proficient in Microsoft Suite applications.EMPLOYMENT HISTORY- Aveva Drug Delivery Systems; Miramar, FL - Senior QA Compliance Specialist(August 2021 - April 2023)- FTF Associates, Inc., Miami Beach, F - President & Senior Consultant(April 1998 - July 2021)- Globepharm Consulting, Northbrook, IL - Senior Consultant; Associate Consultant (Jan 1992 - March 1998)- Organics/LaGrange, Inc., Chicago, IL - Director Quality Operations and Regulatory Compliance (April 1989 - December 1991)- G.D. Searle and Co., R&D Division, Skokie, IL - GMP Compliance and Training Manager - Product Development; Clinical Supplies Production Manager Chemical Development (November 1987 - March 1989- SK&F Lab Co. Guayama, PR - Senior Development Chemist; Production Support; Technical Development Chemist, Production Support(December 1978-April 1987)EDUCATIONBS (Chemistry), Inter-American University of Puerto Rico Certified ISO 9000 Lead Assessor / Auditor (2016)Lead Auditor Certification Apotex Inc. (2020)Professional training courses in basic and advanced supervisory techniques, chemical engineering, experimental design, statistics, communications, management, training skills development, hazard and operability studies, design of stability programs, pharmaceutical plant and process validations and computer systems validation. Detailed descriptions for each job responsibility as well as references can be provided upon request. |
