Z&H Styles

PROFILE A Data Reviewer/Protocol Writer/Stability Coordinator/Laboratory Analyst with over 6 years of experience in a laboratory environment within pharmaceutical and medical settings. Possesses an eye for detail and strong investigative and problem solving skills in order to quickly recognize and document deviations to ensure compliance with SOPs, GMPs, and GLPs. Enjoys new challenges and works well within a team, as well as independently. PROFESSIONAL EXPERIENCE APOTEX INC. Toronto, Ontario 2010 Equipment Facility Quality Team member (Contract, SHEIBCO INC) ? Participated in qualification gap assessment studies. ? Wrote summary reports for seasonal mapping studies of warehouses. ? Perform temperature and humidity distribution studies of stability chambers. ? Prepare IQ, OQ and PQ Protocols for stability Chambers. Pharma Medica Research PMRI, Mississauga, ON 2005 - 2008 R&D Data Reviewer and Product Development Analyst ? Wrote, reviewed and implemented appropriate documentation as needed to maintain regulatory compliance. ? Reviewed method development/validation and informal stability test data to ensure the accuracy and completeness for submissions of new drugs. ? Generated, revised and reviewed SOP’s and performed change controls of methods and specifications as needed. ? Drafted validation protocols for new drug substances and drug products following ICH guidelines and USP requirements. ? Identified atypical results and performed investigations; provided recommendations as needed to management. ? Drafted compliant and user friendly SOPs for lab instrumentation. ? Maintained accurate and complete results on all analyses performed: Assay, RS, Content Uniformity, and Moisture Content using Karl Fisher titration, Weight Variation, Hardness, and Friability. ? Performed HPLC testing using Millennium software and conducted HPLC troubleshooting. ? Trained, coached and mentored lab analysts in the use of HPLC, Karl Fisher, Automated Sotax Dissolution, and Fibroptic Dissolution. GENPHARM, Toronto, Ontario 2004 - 2005 Bio-analytical Analyst ? Reviewed stability data of biological compounds. ? Drafted stability protocols for biological and chemical compounds. ? Predicted shelf lives for drug products based on degradation rate Stability Analyst ? Performed stability study testing on Capsules and Tablets for new drug submissions and market products. ? Performed analytical tests including: Assay, RS, Content Uniformity, and Moisture Content using Karl Fisher titration, Weight Variation, Hardness, and Friability. ? Performed IR for raw material and finished products. ? Conducted dissolution testing using UV and HPLC to analyze extended release drug data. EDUCATION AND TRAINING Diploma of Biochemical Laboratory Science (Major in Microbiology & Biochemistry), Seneca College, Toronto Ontario 2004 PROFESSIONAL DEVELOPMENT ? Ability to motivate juniors ? Ready to learn new facts ? Disciplined ? Confident about completing the work on time ? Obedience ? Punctuality ? Ability to work under pressure ? Ready to face challenges REFERENCES REFRENCES AVAILABLE UPON REQUEST