Harshilkumar Vaghasiya
Ahmedabad
Summary
Analytical Team Leader with extensive experience in pharmaceutical analysis across multiple dosage forms, including topical, injectable, and solid oral products. Currently leading analytical method development, reverse engineering, and NG/G tube study development. Strong expertise in team leadership, GLP compliance, and Quality Management Systems (QMS).
Overview
4
4
years of professional experience
Work History
Team Leader (Reviewer)
ORTIV-Q3 RESERCH PVT. LTD.
Ahmedabad
12.2025 - Current
- Lead and supervise a team of analytical scientists and analysts, ensuring timely execution of development and routine analysis activities.
- Plan, assign, and monitor work for method development, pre-validation, reverse engineering.
- Review and approve analytical data, chromatograms, method development report and study documentation to ensure accuracy, compliance, and data integrity.
- Act as a supporting member for nitrosamine impurity analysis, and extractables and leachables studies.
- Provide hands-on troubleshooting and technical guidance for HPLC, GC, IC, LC-MS/MS and GC-MS instruments.
- Ensure full compliance with GLP requirements and laboratory data integrity standards.
- Coordinate with QA, regulatory, and project management teams to meet project timelines and regulatory expectations.
- Support audits, inspections, and client interactions by presenting technical data and justifications.
- Develop, review, and approve analytical methods, SOPs, protocols, and validation reports.
- Train, mentor, and evaluate team members to enhance technical competency and compliance awareness.
RESEARCH SCIENTIST-1
ORTIV-Q3 RESERCH PVT. LTD.
Ahmedabad
12.2022 - 12.2025
- Performed analytical testing for topical, injectable, and solid oral dosage forms.
- Developed and validated analytical methods for assay, related substances, impurities, and NG/G tube compatibility studies.
- Supported BA/BE studies through bioanalytical and in vitro analytical testing, as per regulatory requirements.
- Executed reverse engineering, method development, validation, and residual solvents, etc.
- Conducted nitrosamine impurity analysis, and supported extractables and leachable (E&L) studies.
- Handled calibration, qualification, and troubleshooting of HPLC, GC, and IC instruments.
- Operated advanced instruments, including LC-MS/MS, GC-MS, ICP-MS, and dissolution systems (USP I, II, IV).
- Worked under strict GLP compliance and actively contributed to QMS activities: Deviations, Incidents, Change Control, CAPA.
- Prepared and reviewed analytical methods, validation protocols, reports, SOPs, and study documentation.
QC OFFICER
STIVAPH HEALTHCARE PVT. LTD
Ahmedabad
06.2022 - 11.2022
- Calibration of instruments.
- Sampling and Analysis of Raw material and in progress sample by UV-Vis spectrophotometer, dissolution, water content by autotitrator etc.
Education
Master of Science - Analytical Chemistry
St.Xavier's College
Ahmedabad05.2022
Bachelor of Science - Chemistry
Sardar Patel University
Anand04.2020
Skills
- Analytical method development and validation (assay, RS, residual solvents)
- Reverse engineering and product development
- Injectables, topicals, solid orals
- NG/G tube study development and validation
- Instrument qualification, calibration, and troubleshooting
- HPLC, GC, IC, LC-MS/MS, GC-MS, PSD
Languages
Gujarati, English, Hindi,
Personal Information
- Date of Birth: 05/09/2000
- Gender: Male
- Nationality: Indian
Timeline
Team Leader (Reviewer)
ORTIV-Q3 RESERCH PVT. LTD.
12.2025 - Current
RESEARCH SCIENTIST-1
ORTIV-Q3 RESERCH PVT. LTD.
12.2022 - 12.2025
QC OFFICER
STIVAPH HEALTHCARE PVT. LTD
06.2022 - 11.2022
Master of Science - Analytical Chemistry
St.Xavier's College
Bachelor of Science - Chemistry
Sardar Patel University