DHANSHREE MHATRE
Thane
Summary
Creating and Revising Finished goods, Product release, Formula devices, and Decorated Components Specifications using the TRU System. Creating Raw Material Questionnaire ID and Raw ID using Raw Material Questionnaire and Raw Material Module. Preparation of SPOOS Report, Spend Report, Financial Payment Report for client
Overview
2
2
years of professional experience
1
1
Certification
Work History
Senior Bussiness Accociate
Tata Consultancy Services
Thane
01.2023 - Current
- Generation and Quality check of FDA FD Reports
- Generation and Quality check of TDOR
- Generation and Quality check of Consolidated Disclosure Report
- Quality check of Spend Report, identify and report financial interest information
- Generate all the reports according to the Standard Operating Procedures and applicable Guidance document
- Conduct and attend meetings with study team as per study requirement
- Meeting project time lines and quality standards set up by the internal client
- Identify/drive areas of process improvement for Client partnership (quality, efficiency, compliance).
Junior Regultory Affairs Specialists
Labcorp
Pune
11.2021 - 10.2022
- Currently involved in project for Global Change Control for EMEA, NA, APAC and LATAM regions with following responsibilities:
- Prepare, Compile and review Regulatory/ Quality documents to support submission to various markets
- Creation and Management of Finished Good, Packaging components specification, Decorated components specification, Product release specification
- Preparation & Modification of Global Change Control
- Perform quality checks on related documents
- Coordinated and interacted with various internal departments, suppliers and distributors to collate information and required documentation governing the changes as applicable
- Prepare post approval supplements/ annual reports to support changes and/or manage regulatory product lifecycle as applicable
- Prepare deficiency responses, review labeling information, product monographs and marketing materials under supervision
- Handling client's requests, suggestions and deciding further actions with help of colleagues and provide support for the dossier compilation
Education
Masters in Pharmaceutical Quality Assurance -
Sinhgad Institute of Pharmacy
01.2021
Bachelors in Pharmacy -
Sinhgad Institute of Pharmacy
01.2019
Skills
- Creating and Revising specifications using TRU System
- Documentation Review
- Communication Skills
- Leadership
- Problem Solving and Motivational Skills
- MS Office
- TRU System
- Veeva Vault
- Prism
- Power BI
- Regulatory Info Management System (RIMS)
- International Module Management System (IMMS)
- Customer Management Tool (CMT)
- Clinical Trials Management System (CTMS)
Certification
- Attended Career Counselling Workshop held by Indian Education Society's Management College and Research Centre in 2019.
- Attended Soft Skill Development Course Held by Mahindra's Pride Classrooms in 2019.
Internship
Worked as an intern in Bharat Serums and Vaccines in Quality assurance and Quality Control Department in July, 2018
Languages
- English
- Hindi
- Marathi
Projects
Quality by design approach for development and validation of HPLC method for Emtricitabine and Tenofovir Alafenamide fumerate in bulk drug. UV-Visible spectrophotometric method for Amlodipine beslyate and telmisartan in bulk and Pharmaceutical dosage form.
Timeline
Senior Bussiness Accociate
Tata Consultancy Services
01.2023 - Current
Junior Regultory Affairs Specialists
Labcorp
11.2021 - 10.2022
Masters in Pharmaceutical Quality Assurance -
Sinhgad Institute of Pharmacy
Bachelors in Pharmacy -
Sinhgad Institute of Pharmacy
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