Rupali Gupta Email & Phone Number

Mississauga, Ontario, Canada

-Effectively worked remotely and on-site handling multiple projects involving collaborations with different stakeholders (Quality Control, Regulatory Affairs, Operations, and Business Management) -Supported Audit team during FDA (2019) and Health Canada (2021) audit as a scribe and document reviewer. -Collaborated with senior management by tracking and.

Mississauga, Ontario, Canada

-Performed Annual Product Quality Review and generated drug product reports in accordance with regulatory, GMP and internal guidelines with 100% OTD -Reconciled data from quality documents (MBR, Change Controls, ARFs etc.) to identify trends in quality issues with 98% RFT -Collaborated constructively with various concerned departments -Handled SOP.

Mississauga, Ontario

- Evaluated, documented, analysed data and created reports for SR&ED tax credit project- Performed review and error check to validate data driven reports- Worked with program management to ensure data collated is CRA audit ready- Obtained list of documents relevant to project through regular meetings with Project Managers- Provided feedback if appropriate.

Mississauga, Ontario, Canada

- Handled data input and prepared various client documents for consent, legal and therapeutic use.- Professionally handled various communications with customers, legal departments and other staff.- Handled inventory, photocopying, mailing and other back office duties.- Managed client bookings, invoices and other financial decisions.- Prioritized and.

-Managed reports of all case types (spontaneous, Phase I-IV clinical studies and post-marketing programs), which included Medical Assessment, Data Management and Quality review.-Maintained rate of 99.99% compliance, by submitting reports within the timelines within which they need to be submitted to the regulatory authorities such as Health Canada, Swiss.

-Processed Individual Case Safety Reports in client's database, including, Data Validation, Triage, Initiation. -Mentored new users through presentations and hands on training. Mentored around 40-45 new users with dedication, patience and enthusiasm. Was able to sign them off with 98% accuracy rate and a healthy professional relationship.-Determined the.

-Trained as a Health Professional with successful managment of patients' needs.-Dealt with multiple patients ranging from paediatric to geriatric in a calm, composed and client oriented manner.-Exceeded the targets with NIL post treatment failures.-Managed Triage in Outpatient Department with accuracy and patience, despite average incoming of 60 patients.