Michael Ehasz

Background

About Michael Ehasz

MICHAEL EHASZ 4468 Portrush Trail Myrtle Beach, SC 29579 mdehasz@sccoast.net Home Phone:843-236-4147 Cell:843-340-0508 Corp. Quality Assurance Consultant Objective To continue to expand my career in pharmaceutical regulatory or quality with an innovative and growing company. Qualifications Over 37 years of Quality Assurance/Quality Control and manufacturing experience Expert knowledge of Quality Systems Management Expert knowledge of FDA, GMP, GLP, and ISO Guidelines as applies to the pharmaceutical industry Working with the FDA through submissions and investigations Implementation of advanced computer solutions for quality management programs and systems that meet FDA and GMP requirements Internal and External Auditing experience Strong leadership skills Experienced in Microbiology; environmental monitoring and a Quality resource concerning sterile drug manufacturing Education B.A. Biology Maryville College Maryville, TN Experience AAIPharma Services Corp. 2320 Scientific Park Drive Wilmington, NC 28405 Corp. Quality Assurance Consultant Present Administration and management of the suppliers/vendor certification program Quality consulting services to Xanodyne Pharmaceuticals Inc, King Pharmaceuticals and AVEVA Drug Delivery Systems First hand experience / Quality consulting services including; 3rd party batch record review, Quality system review / oversight, drug disposition to market as well as Quality system improvement recommendations after firms have received FDA 483’s / Warning Letters