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 trending KPI and conducting quality workshops for the same. KPI improvement rate achieved 112% -Prepared Quality Agreements for approval which helped team with timely submission of regulatory documents-Created quality project plans with established timelines, assigned to appropriate teams and managed workflow throughout -Authored and approved >400 quality records (deviation reports, change controls, complaints) related to site, incoming materials and products -Reviewed master batch records and created Certificate of Analysis (CofA) for final batch release with >97% OTD. -Managed miscellaneous quality tasks assigned by the manager with efficiency

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 revisions in accordance with internal procedures.

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 to make the data collection more efficient

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 workflow to ensure quality and efficient customer service.

-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 Medic etc. in accordance with Clients SOPs and guidelines. -MedDRA coding in accordance with MedDRA Term Selection: Points to Consider-Handled Queries and requesting follow up information for comprehensive case assessment in a professional and humble way-Expertise in handling serious as well as non-serious reports involving Medical Devices. Managed around 900-1000 device reports in a year. -Good working knowledge of ICH guidelines on safety and efficacy, Volume 9a, FDA guidelines, CIOMS and New EU PV legislation-Played an active role in preparation and conduct of Audits, made possible by my efficient interpersonal communication skills and up to date working knowledge of guidelines, Clients Standard Operating Procedures and Global conventions

-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 expectedness of adverse events against various product documents, -Wrote case summaries, -Assessed causalities if required -Wrote CIOMS comments if required, with 99.7% accuracy

-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 daily.-Was instrumental in organisation of and participation in Free Dental Camps.