Harshal Pardeshi
Senior Officer in Analytical Research and Development
Mumbai
Summary
Pharmaceutical Research and development professional with about 5.4 years of analytical development and validation experience. Actively learning, exploring, and honing skills needed for method development and validation along with QMS management.
Proficient in leveraging programming skills and data visualization tools particularly Power BI to extract actionable insights, optimize processes, and support data-driven decision-making.
Overview
5
5
years of professional experience
2
2
Certifications
4
4
Languages
Work History
SENIOR OFFICER
FDC INDIA LTD.
04.2023 - Current
- Responsible for analytical support for drug substances and drug products for ROW and US market.
- Transformed data into required formats using SQL for different analytical elements.
- Developed and presented quality and audit dashboards for the R&D department, delivering key insights to the R&D team.
- Identified the KPI (Key performing indicators) and developed regulatory-compliant reporting dashboards in Excel and Power BI to monitor pharmaceutical product performance, enhancing reporting efficiency.
- Actively involved in analytical method Development followed by method validations for drug products for determination of Assay, Related substances and Dissolution (Type-IV) as per ICH guideline.
- Routine & Stability Analysis for Assay, Related substances and Dissolution (Type-IV), Particle Size by Malvern, Zeta Size Studies.
- Preparation various, validation protocols and reports, Method transfer protocols And Report.
- Demonstrated independent working and communication at plant locations for successful tech transfer activity.
- Coordinating inter department for smooth functioning and meeting the project target deadlines.
- Profound knowledge of QMS activities like handling of Incidents, Deviations, SOP preparations, GLP, GDP and cGMP activities.
EXECUTIVE
SYNGENE INTERNATIONAL
09.2022 - 04.2023
- Involved in Routine Analysis of Stability Samples of Drug Substance and finished products (Tablets, Capsules, Injection, Oral Suspension) for determination of Assay, Related Substances by HPLC.
- Managed and optimized databases using SQL to streamline the storage, retrieval, and analysis of analytical development data.
- Analyzed clinical trial data to assess the efficacy, safety, and bio-availability of injectable formulations, providing key insights into therapeutic outcomes and potential adverse events.
- Performing Dissolution Study for various dosage forms using USP-I, USP-II, USP-V apparatus.
- Forced Degradation Study for Drug substances and Drug product.
- Moisture content analysis by Karl Fischer and Coulometer.
- Communicate and Support to Synthesis team for in-process sample testing.
EXECUTIVE
SHILPA MEDICARE LTD.
02.2021 - 09.2022
- To perform reaction monitoring and Chromatographic purity of Final product's and intermediate product's by HPLC method.
- Conducted forced degradation studies and utilized stability data to evaluate risk factors, documenting findings for regulatory submissions—mirroring predictive analytics and anomaly detection techniques.
- Method development and method validation for determination of Assay and Related Substances in drug substances and products.
- Involved in QMS activities like preparations of validation protocols and reports, SOP, STP.
- Perform routine analysis and Stability batches analysis in Oral Dispersible Film.
- Handling of Diffusion cell to determine drug release.
RESEARCH ASSOCIATE
NSRT, RUSAN PHARMA
11.2019 - 02.2021
- Perform routine analysis and Stability batches analysis.
- Routine calibration of analytical instruments as per calibration schedule.
- Method validation as per ICH guideline for determination of Assay, Related Substances and Dissolution.
- Involved in supporting excel sheet validation to enhance the reporting of the analytical data.
Education
M.Pharmacy - Pharmaceutics
Sandip Institute of Pharmacy, Nashik
08-2019
B.Pharmacy -
Sinhgad Institute of Pharmacy
Pune06-2017
HIGHER SECONDARY SCHOOL - undefined
KTHM Collage
Nashik, MaharastraSECONDARY SCHOOL CERTIFICATE - undefined
Maratha high School
Nashik, MaharshtraSkills
Advance Excel
SQL
Power BI
HPLC ,UPLC
Dissolution Type- I, II, IV, V
Malvern Particle sizer
Malvern Zeta sizer
Certification
Advance Excel (Ira Skills)
Timeline
SENIOR OFFICER
FDC INDIA LTD.
04.2023 - Current
EXECUTIVE
SYNGENE INTERNATIONAL
09.2022 - 04.2023
EXECUTIVE
SHILPA MEDICARE LTD.
02.2021 - 09.2022
RESEARCH ASSOCIATE
NSRT, RUSAN PHARMA
11.2019 - 02.2021
HIGHER SECONDARY SCHOOL - undefined
KTHM Collage
SECONDARY SCHOOL CERTIFICATE - undefined
Maratha high School
M.Pharmacy - Pharmaceutics
Sandip Institute of Pharmacy, Nashik
B.Pharmacy -
Sinhgad Institute of Pharmacy