The document is a resume for Tabasum Ahmed summarizing her experience in quality assurance, auditing, and compliance roles in the healthcare industry over the past 6 years. She has worked at LEO Pharmaceuticals, Lupin Pharmaceuticals, Stafford Communications, Walgreens, and SafeStart Medical focusing on tasks like drafting quality agreements, handling product complaints, implementing quality management systems, and ensuring regulatory compliance. She has a Bachelor's degree in Health Systems Management from Loyola University Chicago where she graduated with honors.
The document is a resume for Tabasum Ahmed summarizing her experience in quality assurance, auditing, and compliance roles in the healthcare industry over the past 6 years. She has worked at LEO Pharmaceuticals, Lupin Pharmaceuticals, Stafford Communications, Walgreens, and SafeStart Medical focusing on tasks like drafting quality agreements, handling product complaints, implementing quality management systems, and ensuring regulatory compliance. She has a Bachelor's degree in Health Systems Management from Loyola University Chicago where she graduated with honors.
The document is a resume for Tabasum Ahmed summarizing her experience in quality assurance, auditing, and compliance roles in the healthcare industry over the past 6 years. She has worked at LEO Pharmaceuticals, Lupin Pharmaceuticals, Stafford Communications, Walgreens, and SafeStart Medical focusing on tasks like drafting quality agreements, handling product complaints, implementing quality management systems, and ensuring regulatory compliance. She has a Bachelor's degree in Health Systems Management from Loyola University Chicago where she graduated with honors.
The document is a resume for Tabasum Ahmed summarizing her experience in quality assurance, auditing, and compliance roles in the healthcare industry over the past 6 years. She has worked at LEO Pharmaceuticals, Lupin Pharmaceuticals, Stafford Communications, Walgreens, and SafeStart Medical focusing on tasks like drafting quality agreements, handling product complaints, implementing quality management systems, and ensuring regulatory compliance. She has a Bachelor's degree in Health Systems Management from Loyola University Chicago where she graduated with honors.
Greater New York City Area | 815-793-2634 | tabasum.ahmed00@gmail.com
Results driven, highly motivated, and detail oriented individual with 6 years of experience in multiple aspects of healthcare including quality assurance, quality agreements, Veeva Vault, audits, and customer service. Looking to bring a strong work ethic, innovating ideas, and a passion to learn to a fast paced environment that leads by example. SKILLS Quality Agreements | Auditing | Client Relations | Veeva | QMS | Biologis | Health Information Management | Compliance | MS Office Suite | Project Planning | Proficiency in Urdu and Hindi EXPERIENCE LEO Pharmaceuticals | Quality Assurance Specialist Madison, NJ | September 2019 - Present ● Draft and finalize Quality Agreements with Contract Manufacturing Organizations (CMOs) ● Receive, process, and close out cases for the Product Quality Complaints received for LEO product and ensure they are handled appropriately to sustain compliance with company standards SOPs and regulatory requirements ● Compile and report Key Performance Indicators (KPIs) quarterly to respective stakeholders ● Implement DSCSA verification process through SAP ● Initiate loss of samples cases, investigate, and report it to the FDA as part of the PDMA notifications ● Provide end user support as the Global, US Affiliate Key Business User in the Electronic Document Management System, maintain user profiles, assign SOPs and ensure completion ● Implement new SOPs, work instructions/processes, maintenance of implemented LEO Quality Management systems to sustain green level compliance, perform Self Inspections of company’s internal departments, and provide assistance during the audits from Health Authorities Lupin Pharmaceuticals | Quality Assurance Compliance Associate Somerset, NJ | March 2019 - September 2019 ● Accurately initiate, assess, and classify received Drug Product Complaints and conduct investigations that include reviewing the concerned batch records, conducting retain sample inspections, and evaluating the returned drug products; including FARs to determine the root cause of the complaints ● Implement appropriate corrective and preventive actions (CAPA) and train required personnel ● Provide comprehensive and organized weekly, monthly, and quarterly quality assurance metrics to support Senior Management Review meetings ● Support all cGMP Electronic Quality System Modules including change control, deviation, and CAPA ● Assisting in the creation of a validated module system within Salesforce for Drug Product Complaints Stafford Communications | Quality Control Compliance Specialist New Providence, NJ | August 2018 - January 2019 ● Effectively support compliance processes and adverse event reporting for a Fortune 500 Pharmaceutical client with high accuracy ● Responsible for supervising team efforts and validating multiple data sets using collaborative tools in order to confirm that quality and targets are met in a timely fashion ● Conduct research and comprehending drug Prescribing Information to identify if client drugs are associated with reportable events Walgreens | Pharmacy Technician Woodstock, IL | November 2017 - March 2018 ● Directly assisted patients on a daily basis to resolve insurance errors, responded to any questions, and insured that there was a clear line of communication between the patient and their doctors ● Quickly and correctly calculated doses, dispensed medications, prepared prescription labels and filled prescription for approval by the pharmacists in a fast paced pharmacy ● Gained experience in using the Walgreens patient portal to input patient information, insurance billing details, prescriptions, and refills both in person and over the phone SafeStart Medical Inc. | HIPAA Compliance Intern Chicago, IL | January 2017 - April 2017 EDUCATION Loyola University Chicago | Bachelor of Science in Health Systems Management Chicago, IL | August 2014 - May 2017 ● 3.7/4.0 GPA | 6 Semester Dean’s List | Scholastic Silver Medallion Graduate | Magna Cum Laude | Upsilon Phi Delta Honors