AF Consulting Group, Inc.

 

 

OUR KEY STAFF Our core consulting professionals have more than 20 years’ experience within the biopharmaceuticals, medical devices, chemicals, consumer healthcare and electronics industries in Puerto Rico and International arena.
Auremir Flores, MS President Sr. Quality Systems & Technical Consultant
EXPERIENCE SUMMARY Over 20 years of experience within the pharmaceutical business, specializing in regulatory affairs, compliance (QA/QC) systems, and validation project management execution. Ms. Flores has strong hands-on experience in the integration of process validation, equipment qualification, cleaning validation, commissioning, CMC analysis, eCTD build and process start-up under quality systems and risk-based analysis concepts. Ms. Flores has managed compliance projects in the area of biological, sterile, API, consumer healthcare, medical devices as well as solid dosage products.
MAJOR CLIENTS MCNEIL HEALTHCARE LLC – LAS PIEDRAS HOSPIRA – NORTH CAROLINA PFIZER – COSTA RICA & GLOBAL SERVICES - CONNECTICUT AMGEN MANUFACTURING LIMITED – JUNCOS BRISTOL MYERS SQUIBB HOLDING PHARMA LIMITED – MANATÍ HEWLETT PACKARD – AGUADILLA / IRELAND MEDTRONIC NEURO-DIABETES – JUNCOS ARMSTRONG LABORATORIES – MÉXICO WYETH-AYERST LEDERLE – CAROLINA LILLY DEL CARIBE PR03 ORTHO BIOLOGICS – MANATÍ
José H. Flores, BSChE Sr. Process Engineering & Environmental Consultant
EXPERIENCE SUMMARY Over 27 years of proven experience in both team and project management. Hands-on Electronics, API Bulk and Bio-pharmaceutical (Bulk Active Ingredients product transfers and Batch Campaign set up/ Insuline startup process) manufacturing operations and Hazardous Waste management, transportation and disposal into USA facilities. Ability to work autonomously and as a team player, with demonstrated strengths in managing and solving complex situations. Flexibility to move forward with new changes, providing open communication and potential risk involved. Maintain focus to achieve goals while ensuring problems solutions within the organization targets. Exceptional communicator focused on building strong organization relationships.
MAJOR CLIENTS Heritage Environmental Services - Mayaguez Lilly Del Caribe Inc. - Mayaguez Merck Sharp & Dohme - Arecibo Viasystems - San Germán Digital Equipment - San Germán Silicon General - Aguada