Damodhar Khedekar
Nagpur
Summary
Senior Process Associate with 4 years of experience at Tata Consultancy Services and 3.5 years of experience as quality assurance executive in pharma industry, excelling in quality review, reconciliation, medical writing, ICSR case processing. Seeking an opportunity to utilize expertise in a challenging and innovative organization.
Overview
8
8
years of professional experience
Work History
Senior Process Associate
Tata Consultancy Services (TCS)
Nagpur
08.2021 - Current
- Handling Inline and end of line quality review, reconciliation of the clinical study.
- ICSR case processing of clinical trial reports, Partner reports, regulatory authority reports, literature reports.
- Proficient in writing descriptive narratives.
- Proficient in using MedDRA, CCD and WHO Drug dictionary.
- Good understanding of drug development process and Clinical trials.
- Ability to prioritize, plan and organize work assignments and able to work under strict timelines.
- Worked on the EDC like RAVE and Sitero mentor.
Executive (Quality Assurance)
Lupin Limited
Nagpur
01.2020 - 07.2021
- Handling in-process quality assurance and documents management activity.
- Review of BMR, BPR and validation protocol.
Executive (Quality Assurance)
Sun Pharmaceuticals Ltd
Goa
11.2017 - 01.2020
- Handling in-process quality assurance and documents management activity.
- Review of BMR, BPR and validation protocol.
Education
M.Pharma - Pharmaceutical chemistry
Department of Pharmaceutical sciences, Nagpur University
Nagpur07-2017
B.Pharma - Pharmacy
Agnihotri College of Pharmacy
Wardha06-2015
Skills
- ICSR quality reviewer and reconciliation of clinical study
- Medical writing
- ICSR case processing
- Worked on database Sapphire and Argus
- Strong written and verbal communication
- Good analytical problem solving and time management
- Good listener and quick learner
Projects
Development and Validation of Bioanalytical Method for the Determination of Novel Drug in Rat Plasma, 6 Months, The research work includes analytical as well as bioanalytical method development and its validation along with determination of drug contents in rat plasma.
Courses Certifications
Sun Pharma Quality Training, 01-Nov-2017
Personal Information
- Total Experience: 7 Years 5 Months
- Date of Birth: 13-Jun-1994
- Gender: Male
- Marital Status: Married
Languages
English
Proficient
C2
Hindi
Proficient
C2
Marathi
Proficient
C2
Timeline
Senior Process Associate
Tata Consultancy Services (TCS)
08.2021 - Current
Executive (Quality Assurance)
Lupin Limited
01.2020 - 07.2021
Executive (Quality Assurance)
Sun Pharmaceuticals Ltd
11.2017 - 01.2020
M.Pharma - Pharmaceutical chemistry
Department of Pharmaceutical sciences, Nagpur University
B.Pharma - Pharmacy
Agnihotri College of Pharmacy