●HPLC (Shimadzu LC 2010HT, Prominence LC20AD, ThermoFisher scientific Ultimate 3000, Agilent) ●GC ●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)
Akshaykumar Patel
QC Chemist
Hampton Park,VIC
Summary
Versatile Senior Officer in Pharmaceutical Quality Control with 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 AU
05.2023 - Current
- The responsibility includes conducting physical testing such as Appearance, Loss on Drying (LOD), Identification (ID) tests, water content analysis, hardness testing, residue of ignition assessment, and other relevant tests for raw materials, in-process materials, and finished products.
- 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.
- Demonstrated an in-depth understanding of ISO90001, ISO14001, and ISO45001, ensuring compliance with international quality, environmental, and occupational health standards.
- Monitored production output to verify quality standards ahead of dispatch.
- 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
- Spearheaded the analytical method development for Assay and Dissolution, demonstrating proficiency in advancing testing protocols.
- Expertly operated a diverse range of chromatography instruments, including HPLC, UV, TLC, and IR.
- Applied a deep understanding of ICH, USP, BP, and IP pharmacopeias guidelines to ensure rigorous adherence in analytical processes.
- Conducted meticulous analysis of stability samples following F&D department protocols on HPLC.
- Successfully executed a comprehensive multimedia Dissolution study for a novel drug in alignment with method development.
- Consistently performed routine analyses of stability samples, focusing on Dissolution, Assay, and Impurity Tests.
- Maintained a strong foundation in Good Laboratory Practice (GLP) and Good Documentation Practice (GDP).
- Actively engaged with the team, playing a key role in collaborative efforts and fulfilling related tasks and responsibilities.
Quality Control Lab Officer
Intas Pharmaceticals 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.
- Contributed to operations within a USFDA-approved plant, adhering to stringent regulatory standards and ensuring compliance.
- Successfully performed precise calibration of HPLC instruments, validating their accuracy and reliability in analytical procedures.
Research Associated
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.
- Conducted precise calibration of HPLC instruments, validating their accuracy and reliability for accurate analytical results.
- Collaborated with cross-functional teams to enhance process efficiency and facilitate effective communication across departments.
Education
Master of Science - Organic Chemistry
B.N Patel College of Science- S.P University
India 04.2001 -
Bachelor of Science - Chemistry
Bhavna's Science of College- Gujarat University
India 04.2001 -
High School : 12th Science - Maths Group
Satasangi Vidhyalay
India 04.2001 -
SSC -
Shreeji Vidhyalay
India 04.2001 -
Skills
Analytical skills
Software
Work rights & Notice Period
- Visa Status: On a Spouse visa with full-time work rights as my partner pursuing a master’s degree.
- Notice Period: 1 month
Timeline
Quality Control Chemist
CosmaxNBT AU
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 Pharmaceticals Ltd. SEZ Plant
11.2019 - 04.2021
Research Associated
Dishman Carbogen Amcis
06.2018 - 05.2019
Master of Science - Organic Chemistry
B.N Patel College of Science- S.P University
04.2001 -
Bachelor of Science - Chemistry
Bhavna's Science of College- Gujarat University
04.2001 -
High School : 12th Science - Maths Group
Satasangi Vidhyalay
04.2001 -
SSC -
Shreeji Vidhyalay
04.2001 -
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