Devangi Patel Email & Phone Number

• Managed product reconciliation for product complaints and adverse events with pharmacovigilance • Assisted in development and implementation of global automated reconciliation tool, resulting in maximized efficiency, compliance and elimination of 40+ hours bi-monthly manual reconciliation • Supported innovation project to enhance global training system • Designed and implemented job aides to assist onboarding employees and minimizing hands-on training • Ensured all work (i.e. investigations, complaints, action items, follow ups, etc.) was performed and documented accurately, timely and in compliance with internal procedures• Authored quarterly product complaint trend reports, initiate trend investigations, related CAPA trend analysis records and evaluate metrics for quality impact and adverse trends• Managed the receiving and handling of all Product Quality Complaints for medicinal products and combination products in compliance with 21CFR Parts 210, 211 820 • Reviewed completed complaint files to assure proper documentation, coordination, investigation, resolution and closeout • Gathered data to assist with any potential recall and/or reporting actions • Prepared Annual Product Review (APRs) for products• Identified areas of improvement and supports department continuous improvement activities

• Recorded and compiled test results for research and product development • Analyzed results to classify projects and product comparison • Mixed, blended and cultivated ingredients to make reagents for food products • Practiced safety procedures and health code regulated handling

• Performed passive range of motion on patients and patient care • Assisted in ambulating cardiac surgery patients in post-surgery recovery • Observed coronary artery bypass grafting and heart valve replacement surgery • Recorded cardiovascular measurements and documented progression of patient recovery