Alexander Thomas

Background

About Alexander Thomas

SUMMARY Over 15 years of extensive experience as an analytical chemist, Project Lead, Supervisor and Manager in QC laboratories in pharmaceutical, biotechnology, chemicals and cosmetic companies. •Excellent supervisory and management experience over five years. •Excellent knowledge in Quality Systems, and FDA’s six system approach for quality audit. •Working knowledge of using Quality tools, Process Improvement tools, Innovation & creativity tools, and Cost of Quality. •Excellent knowledge of GMP, GLP, GCP, NDA/IND, Drug Development, SPC and Complete Drug life Cycle. •Over 10 years of Experience with LIMS and Database Management System (SAP). •Over 5 years of experience as the LIMS Lab approver for Raw materials and finished products of Roche Molecular systems. •Over 5 years of project management experience and PMP certified. Familiar with MS Project 2010 •Investigated testing abnormalities and implemented corrective and preventive actions. •Determined root causes of non-conformances and recommended corrective actions. •Conducted periodic lab audits by reviewing the documentation, device history records, log books, etc, to ensure that the QC Lab met the requirements of cGMP and 21CFR Part 11 compliance. •Coordinated testing responsibilities to ensure QC releases raw materials and bulks according to the needs of Manufacturing to maintain continuous process flow. •Led the validation of test methods and lab qualification for test methods. •Led the cleaning validation of manufacturing plant using Total Organic Carbon analyzer (TOC). •Extensive experiences and in-depth knowledge of analytical instrumentation and modern methodologies such as GC, HPLC, UV-VIS, FT-IR, TOC & Coagulation analyzer, Particle size analyzer, Titrators, and Dissolution etc. •Developed and validated Analytical Methods. •Familiar with GMP/GLP/GCP, Quality Assurance and Regulatory Affairs. •Excellent communication, interpersonal, documentation, and computer skills. Specialties: Quality Assurance and Regulatory Affairs, Project Management, GMP