Akshaykumar Patel
Hampton Park,Australia
Summary
Versatile Senior Officer in Pharmaceutical Quality Control with over 5 year experience and expertise in analyzing raw materials, in-process and finished goods, and conducting stability studies for a range of pharmaceutical products. Proficient in adhering to GMP and GLP standards within US FDA-approved plants. Experienced in method development and validation, ensuring the accuracy of analytical processes. Proven track record of fostering an open and collaborative culture within the laboratory. Eager to take on new challenges and contribute expertise to a growth-oriented company.
Overview
6
6
years of professional experience
Work History
Quality Control Chemist
CosmaxNBT
05.2023 - Current
- Proficiently conducted chemical testing utilizing High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC-FID), alongside physical testing employing Atomic Absorption Spectroscopy(AA) and Ultraviolet (UV) spectroscopy methods,
- Additionally, the role involves performing Assay, Disintegration, Impurity, and various other tests to ensure the quality and compliance of the tested materials throughout the manufacturing process
- Proficient in employing both wet and instrumental techniques for testing purposes
- The role involves the development and optimization of test methods as an integral part of new product launches or method improvement initiatives
- Addressed non-conformance issues, pausing production to correct errors
- As a detail-oriented professional, I took on the crucial task of preparing vital test solutions and reagents, ensuring their precision and readiness for thorough analyses
- I skillfully calibrated advanced instruments, such as HPLC, pH meters, UV spectrophotometers, FT-NIR, FT-IR, and Karl-fisher titration, strictly following established Standard Operating Procedures (SOPs)
- A critical facet of my role involved troubleshooting issues related to new raw materials tests and instruments
- My capacity to quickly acquire and apply new skills was evident in my daily tasks, markedly improving efficiency and productivity in testing and validation processes
- The ability to adapt to changing requirements and a dedication to continuous improvement had a positive impact on overall operational efficiency.
QC Lab Technician
Ennis-Flint Traffic Safety Solution
03.2022 - 05.2023
- Conducted comprehensive softening point, luminance, and flow and viscosity tests on the product to ensure quality standards.
- Executed precise calibration of laboratory instruments in adherence to the calibration register, ensuring accurate and reliable measurements.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Evaluated samples against standards by completing measurements, visual inspections, and other established tests.
- Helped uncover and fix production problems in order to reduce overall defect rates.
- Maintained quality documentation and records for conformance with relevant standards.
- Developed and implemented quality control processes to meet product standards.
- Collaborated with production staff to improve processes, reduce defects and optimize quality.
- Upheld a steadfast belief in teamwork, fostering a collaborative and positive work environment.
Analytical Lab Officer
Concord Biotech Pvt Ltd
05.2021 - 01.2022
- Led analytical method development for Assay and Dissolution, showcasing expertise in enhancing testing protocols.
- Operated diverse chromatography instruments proficiently, including HPLC, UV, TLC, and IR.
- Ensured strict adherence to ICH, USP, BP, and IP pharmacopeias guidelines, guaranteeing regulatory compliance in analytical processes.
- Conducted precise analysis of stability samples on HPLC following F&D department protocols.
- Successfully completed a comprehensive multimedia Dissolution study for a novel drug, aligning with method development objectives.
- Consistently conducted routine analyses of stability samples, focusing on Dissolution, Assay, and Impurity Tests.
- Maintained adherence to Good Laboratory Practice (GLP) and Good Documentation Practice (GDP) standards.
- Actively collaborated with the team, contributing to collective efforts and fulfilling related tasks and responsibilities.
Quality Control Lab Officer
Intas Pharmaceuticals Ltd. SEZ Plant
11.2019 - 04.2021
- Conducted meticulous HPLC analysis for finish and in-process oncology samples, ensuring precision and reliability in results.
- Demonstrated a strong understanding of Good Laboratory Practice (GLP) and Good Documentation Practice (GDP), maintaining a commitment to high-quality standards.
- Proficient in diverse sample analyses, encompassing Tablets, capsules, Injections, SVP, and LVP, showcasing a comprehensive range of analytical skills.
- Possess troubleshooting expertise related to instruments, contributing to the seamless operation of laboratory equipment.
- Executed a variety of tests, including Assay, Related Substances, and Dissolution, showcasing a thorough understanding of quality control processes.
- Successfully performed precise calibration of HPLC instruments, validating their accuracy and reliability in analytical procedures.
Research Associate Intern
Dishman Carbogen AMCIS
06.2018 - 05.2019
- Executed diverse reactions ranging from milligrams to kilograms for batch scale-up, demonstrating versatility in managing various reaction types.
- Innovatively identified new routes for all API drugs, contributing to optimization and improvement of manufacturing processes.
- Applied troubleshooting expertise to address instrument-related issues, ensuring seamless functioning of laboratory equipment.
- Operated within USFDA-approved plant, adhering to stringent regulatory standards and maintaining commitment to quality assurance.
Education
Master of Science - Organic Chemistry
B.N Patel College of Science
Sardar Patel University03.2018
Bachelor of Science - Chemistry
Bhavna's Science of College
Gujarat University03.2016
Skills
- Analytical skills
- Chromatography Techniques
- Laboratory compliance
- Task completion
- Troubleshooting & Problem-solving abilities
- Instrument Calibration
- Chemical Analysis
- LIMS
- Effective Communication
- Time Management
Instruments Skill
- HPLC (Agilent, Shimadzu LC 2010HT, Prominence LC20AD)
- GC-FID
- UV Spectroscopy
- Polarimeter
- Auto Titrator
- Karl Fisher (Water)
- FT-IR (Bruker) & FT-NIR (Bruker)
- Dissolution (ELECTROLAB)
- Particle size Analyzer (MALVERN 3000)
- PH meter
- Hardness
- Microbalance
- Refractometer
- TLC (Thin layer Chromatography)
Timeline
Quality Control Chemist
CosmaxNBT
05.2023 - Current
QC Lab Technician
Ennis-Flint Traffic Safety Solution
03.2022 - 05.2023
Analytical Lab Officer
Concord Biotech Pvt Ltd
05.2021 - 01.2022
Quality Control Lab Officer
Intas Pharmaceuticals Ltd. SEZ Plant
11.2019 - 04.2021
Research Associate Intern
Dishman Carbogen AMCIS
06.2018 - 05.2019
Master of Science - Organic Chemistry
B.N Patel College of Science
Bachelor of Science - Chemistry
Bhavna's Science of College
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