TAhmed Resume 02 2023

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TABASUM AHMED

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

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