Ashima Bansal Gupta Email & Phone Number

Gurugram, Haryana, India

Gurugram, Haryana, India

Gurgaon, India

• Currently managing a $14 million global regulatory affairs remediation project of ~87 resources to remediate documents like STED files, EU tech files, instructions for use, etc. as well as complete any resulting international product license re-registration• Collect business requirements and develop scope of the project accordingly• Develop process maps and project execution strategies• Generate project charter, budget estimate, resource estimate, timeline and key performance indicators/trackers• Calculate and track the actual spent to date, as well as set up the global cost centers to record the regional project costs. Work with global finance teams and set up a process to harmonize the cost reporting system for this project.• Managing a team of 87 resources spread across approximately 20 countries and speaking different languages. Responsible for the end to end recruiting/onboarding process.• Regularly report out the project status and updates to internal and external stakeholders/vendors• Identify risks/issues and drive resolutions

Parsipanny Nj

• Led a multimillion-dollar 2-year global regulatory integration project for completion of all license re-registrations across 237 countries as a result of Zimmer and Biomet merger.• Managed an IT project for implementation of Global Trading System to establish robust and compliant distribution controls.• Spearheaded a Regulatory Affairs process improvement project to develop an effective process and KPI for management of International Registration Requests

Austin, Texas Area

•Managed the operational execution of an Emergency Use Authorization product launch in collaboration with project manager. Authored stability protocol for the product.•Implemented smart spreadsheets to improve efficiency of business metrics reporting system for the reagent & bioassay operation. Monitored & presented performance of the operation by creating monthly scorecards, graphs, presentations, reports, etc. Generated models to plan & predict the quality goal attainment.•Improved the efficacy of entire reagent stability program by 80% through automation of the stability study management protocol utilizing various oracle applications.Acting subject matter expert for the stability program.•Actualized huge cost savings in the hazardous waste disposal system for the Organization, by harmonizing the disposal system site wide amongst other improvements implemented. Ensured company’s compliance with all the OSHA regulations & obtained TCEQ permits, working along with the chemical safety officer.•Managed and coordinated new product packaging and labeling activities. •Resolved packaging related customer complaints and CAPAs along with packaging engineer.•Successfully launched product as an Associate Design Transfer & Process Engineer:-Engineered the technical design & process development. Authored and executed qualification/ validation protocols.•Successfully delivered projects as an Associate Project Manager: -Authored project documents like DHFs, DHFIs, customer and product requirements etc.•Performed internal quality assurance audits.•Performed quality control testing in BSL2 Lab - identification testing, enumeration testing, attribute testing, generated certificate of quality, ran assays, generated & maintained retention logs.•Performed equipment validations & spreadsheet validations. Supported CAPA & NCMR closures.

•Delivered effective design change documentation, ensuring compliance to Operating Procedures, Standards and Government Regulations. •Coordinated with different departments like Supplier quality, Engineering, TPD, Systems Integration and R&D to ensure the timely completion of the tasks with compliance to Abbott Quality Policies.•Utilized project management skills to make sure that all the requests and tasks are completed on time and efficiently. Delivered status updates for the same during weekly meetings.•Provided effective database services, through investigating, troubleshooting and/or coaching efforts, to resolve issues with respect to database tools.•Subject Matter Expert for the software legacy project. Helped in the establishment and maintenance of the operating procedures. •Scribed for audit (ASQ and ISO).

Introduction To Bioengineering

•Prepared instructional material & classroom displays for “Introduction to Bioengineering” course under guidance of the professor.•Mentored students with their assignments and subject related problems, to help them develop a better understanding.•Graded student assignments and exams.

•Coached undergraduate students with homework assignments, exam preparations etc. utilizing communication and team work skills for individual and collaborative settings.•Meticulously review student work to ensure they understand and achieve correct solutions.

Master'S, Bioengineering

Activities and Societies: Cell Culture

Bachelor'S Degree, Bioengineering And Biomedical Engineering, 4.0