Over twenty four (26) years of experience in the quality assurance, pharmaceutical, biopharmaceutical, veterinarian products, and medical device industries. Expertise in Quality Systems, Quality Assurance and Computer and Equipment Validation including SOP development, risk assessments, quality reviews, protocol IQ/OQ/PQ development and execution, project management, outside vendor selection, development of project time lines, scheduling of outside vendor services, scheduling of in-house QA/ QC services, resolution of compliance issues, and QA batch and clinical data reviews.
Specialties: Expertise in Quality Systems, Quality Assurance, Computer and Equipment Validation including SOP de...
