Chattanooga, Tennessee Area United States
Consultant at TL Fortune, LLC
Medical / Health Care / Pharmaceuticals
SUMMARY OF QUALIFICATIONS
• GMP Quality Professional for over 23 years
• Ph.D. in Organic Chemistry
• Experienced with drug substance, drug product (Ethical and OTC), Phase I/II CTMs
• Experienced evaluating and developing Core Quality Systems
• Experienced developing and delivering GMP Training
• Computer System Validation – Responsible for site compliance and authored protocols
• Working on cross functional teams for process improvements and integration activities
• Batch review and release – production and QC documentation
• Oversight of QC Laboratory
• Experienced preparing and presenting Management Review KPIs, metrics, and dashboards