Shaneca Roberts

Background

About Shaneca Roberts

A trained Chemist with a successful track record in GMP auditing. I am passionate about supporting pharmaceutical companies achieve their inspection readiness and compliance goals. I have over 20 years experience in Medical Devices, Vaccines, and Pharmaceuticals within North America, Europe, and Asia. Personal Skills- Rich understanding of all aspects governing Quality Control and Inspection activities- Achieve high quality results while working under pressure- Leader of team and projects, managing indirect reports in compliance activities- Brings structure and calm approach into “mock” inspection activities- Excellent communication and organizational skills. Functional Skills- United States Pharmacopoeia (USP) and European Pharmacopoeia (EP)- US FDA 21 CFR Part 820; 21 CFR Part 11; 21 CFR Part 211; ISO 13485: Medical Devices; ISO 14971- EMEA, EMA, ANSES, MHRA, VMD, ANVISA, MAPA, Russia Regulations, Turkey Regulations- Expert knowledge of SharePoint- Expert knowledge of TrackWise