RUPALI GUPTA
Carleton Place,ON
Summary
Talented professional considered knowledgeable leader and dedicated problem solver. Brings 10 years of quality expertise from pharmaceutical manufacturing to forward company objectives. Adept at working effectively unsupervised and quickly mastering new skills. Good understanding of GMP, FDA, Health Canada regulations.
Overview
11
11
years of professional experience
Work History
PROJECT MANAGER (QUALITY)
ThermoFisher Scientific
06.2020 - 12.2023
- Authored and approved >400 quality records (deviation reports, change controls, complaints) related to site, incoming materials and products
- Reviewed master batch records, created Certificate of Analysis (CofA) for final batch release with >97% OTD.
- Prepared Quality Agreements for approval
- Supported Audit team during FDA (2019) and Health Canada (2021) audit as a scribe and document reviewer.
- Created quality project plans with established timelines, assigned to appropriate teams and managed workflow throughout
- Collaborated with senior management on improvement initiatives by conducting quality workshop.
- Managed multiple projects and high volume clients with competing deadlines simultaneously
QUALITY SPECIALIST
ThermoFisher Scientific
04.2019 - 06.2020
- Performed Annual Product Quality Review and generated drug product reports in accordance with regulatory, GMP and internal guidelines
- Reconciled data from quality documents (MBR, Change Controls, ARFs etc.) to identify trends in quality issues
- Collaborated constructively with various concerned departments
- Handled SOP revisions in accordance with internal procedures.
PROJECT SUPPORT COORDINATOR
ThermoFisher Scientific
10.2018 - 04.2019
- Obtained list of documents relevant to project through regular meetings with Project Managers
- Prepared and analyzed data from project documents (protocols, change control etc.)
- Worked with program management to ensure data collated is audit ready
- Created reports while ensuring adherence to regulatory and company guidelines.
PHARMACOVIGILANCE ANALYST
Parexel
06.2013 - 04.2018
- Performed Quality Review of reports originating from Phase I-IV clinical trials
- Assisted managers in reconciliation, identifying trends and writing Root Cause Analysis
- Prepared adverse event reports for submission to various HA including Health Canada
- Performed medical assessment for suspect identification, seriousness in Global Safety Database.
Education
Bachelor of Dental Surgery -
Baba Farid University of Medical Sciences
01.2012
Skills
- Communication Proficiency
- Documentation and Reporting
- Quality Management Systems
- Client Relations
- Decision-Making
- Detail Oriented
- Multiple Priorities Management
- Cross-Functional Collaboration
Languages
English
Full Professional
Timeline
PROJECT MANAGER (QUALITY)
ThermoFisher Scientific
06.2020 - 12.2023
QUALITY SPECIALIST
ThermoFisher Scientific
04.2019 - 06.2020
PROJECT SUPPORT COORDINATOR
ThermoFisher Scientific
10.2018 - 04.2019
PHARMACOVIGILANCE ANALYST
Parexel
06.2013 - 04.2018
Bachelor of Dental Surgery -
Baba Farid University of Medical Sciences
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