Mansi Patel
Wembley,City of London
Summary
Highly skilled analytical professional with extensive expertise in advanced techniques including HPLC, UPLC, FT-IR, UV-VIS, and dissolution testing. Proficient in method development and validation for assays, impurity profiling, stability testing, and method transfer. Demonstrates exceptional capability in laboratory operations such as equipment calibration, troubleshooting, and continuous process improvement. Adept at regulatory compliance with EU GMP, USFDA, ANVISA standards and experienced in managing corporate and customer audits across multiple regions. Skilled in utilising software tools like Chromeleon 7.2, Empower 3, Lab Solution to streamline processes and ensure data accuracy. Committed to maintaining high-quality standards through effective auditing practices and comprehensive documentation including SOPs and CAPA management.
Overview
5
5
years of professional experience
Work history
QC Analyst
Prime Labs Ltd.
Watford, Hertfordshire
2025.07 - Current
- Assisted in transferring analytical methodologies utilising high performance liquid chromatography (HPLC).
- Supported the development and execution of protocols for Analytical Method Transfer (AMT) to maintain accuracy and compliance.
- Conducted analyses of finished products using HPLC techniques for substances like paracetamol and ibuprofen.
- Performed stability sample analyses in line with established specifications using various analytical techniques including HPLC, UPLC, GC, dissolution, FT-IR, and UV.
- Aided in audits and ensured documentation complied with GMP regulations.
Officer - Quality Control
M/s. Zydus Lifescience Limited, Ahmedabad
Ahmedabad, Gujarat
2020.09 - 2025.03
- Development and validation of an analytical methodology utilizing High-Performance Liquid Chromatography
- (HPLC).
- Performed method validation, method transfer and method feasibility studies.
- Followed different pharmaceutical methods for testing.
- Ensure all laboratory analysis is compliant and according to the relevant quality standards.
- Performed analysis of stability sample.
- Interpreted analytical data, details, and findings and provided relevant data to support conclusions.
- Troubleshooting, and maintenance of analytical instrumentation.
- Instrument calibration and comprehensive documentation of analytical procedures and activities.
- Ensuring all activities are performed in compliance with customer and ICH procedures.
- Tests and analyses pharmaceutical drugs to determine their identity, purity, and strength.
- Completed quality control tests and maintained equipment to keep result reliable and accurate.
Education
Master of Science - Organic Chemistry
Gujarat University
Ahmedabad India 01/2018 - 01/2020
Bachelor of Science - Chemistry
Gujarat University
Ahmedabad India 2015 - 2018
Skills
- Analytical Techniques: HPLC, UPLC, FT-IR, UV-VIS, Karl Fischer, Dissolution Testing
- Method Development & Validation: Assays, Impurity Profiling, Stability Testing, Method Transfer
- Laboratory Operations: Equipment Calibration, Troubleshooting, Continuous Process Improvement
- Software Expertise: Chromeleon 72, Lab Solution, Tiamo
- Auditing & Documentation: Regulatory Inspections, SOPs, CAPA, Data Interpretation & Reporting
- Regulatory Compliance: EU GMP, USFDA, ANVISA, Saudi Arabia, Libya MoH, Corporate Audits and Customer Audit multiple times at Site
Languages
Hindi
Fluent
Gujarati
Native
English
Advanced
Affiliations
- Continuous learning in pharmaceutical regulation
- Scientific literature reading and review.
- Playing chess and solving puzzles
Timeline
QC Analyst
Prime Labs Ltd.
2025.07 - Current
Officer - Quality Control
M/s. Zydus Lifescience Limited, Ahmedabad
2020.09 - 2025.03
Master of Science - Organic Chemistry
Gujarat University
01/2018 - 01/2020
Bachelor of Science - Chemistry
Gujarat University
2015 - 2018