Akshay Patel

Detail-oriented and results-driven Quality Control (QC) & Analytical R&D Scientist with extensive experience in pharmaceutical analysis, method development, and regulatory compliance. Proven expertise in HPLC, GC, UPLC, FT-IR, UV-VIS, and other analytical techniques. Adept at optimising laboratory operations, ensuring regulatory adherence (MHRA, USFDA, ICH), and driving process improvements.

Passionate about delivering high-quality analytical solutions to enhance product efficacy and compliance.

Quality Control (QC Analyst) at Prime Labs Ltd. (2025-06 – Present)

Analytical method transfer and validation using HPLC with comprehensive protocol design ensuring accuracy, compliance, and reproducibility.

• Analytical method transfer of a methodology using High-Performance Liquid Chromatography (HPLC)
• Designed and implemented a comprehensive protocol for Analytical Method Transfer (AMT) and Analytical Method Validation (AMV), ensuring accuracy, compliance, and reproducibility of analytical results
• Undertaking the analysis of finished products and stability samples according to established specifications using analytical techniques and wet analysis (HPLC, GC, Dissolution, ICP, FT-IR, UV, LOD, ROI, etc.)
• Supporting audits and ensuring all documentation is in adherence with GMP regulations

Quality Control/AR&D (Executive) at BDR Pharmaceutical International Pvt Ltd. (2022-11 – 2023-09)

QC and analytical R&D operations in GMP facilities with regulatory audit experience and ICH compliance oversight.

• Experience of working in GMP facilities and experience in facing regulatory audits like USFDA
• Ensuring all activities are performed in compliance with customer and ICH procedures
• Interpreted analytical data, details, and findings and provided relevant data to support conclusions
• Regularly helped in performing continuous improvements in the Lab to keep the processes running smoothly and achieve higher efficiency
• To ensure that all work carried out complies with departmental procedures and is cGMP compliant

Quality Control/Analytical R&D (Senior Officer) at Apothecon Pharmaceutical Pvt Ltd. (2019-07 – 2022-08)

Development and validation of analytical methodologies with focus on HPLC method validation, method transfer studies, and stability testing.

• 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

Quality Control/Analytical R&D at Apicore Pharmaceuticals Pvt Ltd. (2017-03 – 2019-07)

Operation and calibration of multiple analytical instruments with chemical analysis expertise including wet analysis, reaction monitoring, and stability testing.

• Operation and Calibration of instruments like Analytical balance, pH-meter, KF, FT-IR, UV, LOD, Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), UPLC, Dissolution, Particle Size Distribution (PSD), ICP
• Performing of chemical analyses, including Wet analysis like physical property assessments, Karl Fischer (KF) titration, Residue on Ignition (ROI), and Loss on Drying (LOD) determinations
• Analysis of Reaction monitoring of intermediate, Finished product, Raw Material, Complete Analysis as per requirement, Standard Qualification, and Impurity Qualification
• Analysis of in-process sample, Batch release and Stability sample by HPLC and GC
• Software Handled: Chromeleon 7.2, Empower 3, Lab solution, tiamo, Marvel 3000
• Performed analysis of stability sample

R&D (Senior Research Associate) at Piramal Pharma Solution (2016-08 – 2017-03)

Experimental research and product development with compound separation and purification expertise.

• Conducted Experimental Research
• Product development
• Separate and purify compounds from a mixture based on their different affinities for a stationary phase within a column

MSc in Analytical Chemistry – Sheffield Hallam University (2023-09 – 2024-06)