Empower, Lab solution,Qbd method development software
KAMARAJ R
Executive-Analytical Research & Development
Krishnagiri
Summary
Analytical Chemist with 4.5+ years of experience in method development, validation, transfer, and routine analysis using HPLC, UPLC, and GC. Strong knowledge of ICH, GLP, GDP, and ALCOA++ data integrity principles. Experienced in Injectables,CRO and API analysis, documentation, and GLP compliance
Overview
3
3
Languages
4
4
years of professional experience
Work History
Executive Scietist
Syngene International Limited
07.2024 - Current
- Developed, validated, and transferred analytical methods using UPLC, HPLC, and GC systems to ensure compliance and enhance reliability.
- Experienced in amino acid analysis and impurity profiling for injectable formulations.
- Prepared validation protocols, reports, and technical documentation in accordance with ICH guidelines to support regulatory submissions.
- Troubleshot analytical methods and optimized chromatographic conditions to improve method performance and accuracy.
- Skilled in preparing validation and transfer protocols,reports and development study reports.
Executive
Solara Active Pharma Sciences
08.2022 - 05.2024
- Experienced in analytical method development and validation for raw materials, intermediates, and finished APIs using HPLC and GC.
- Conducted routine analysis and reaction monitoring for development and process samples using HPLC, GC, LOD, and KF to ensure project milestones were met.
- Compiled analytical test reports (ATR), certificates of analysis (COA), and validation reports to support regulatory compliance and project documentation.
- Conducted instrument calibration and column performance checks for HPLC and GC systems.
- Troubleshot HPLC and GC instruments and resolved technical issues.
- Worked with pharmacopoeial methods (USP, IP, EP) for analytical testing.
- Prepared analytical test reports (ATR), certificates of analysis (COA), and validation reports.
- Diagnosed and resolved technical issues with HPLC and GC instruments to maintain operational efficiency and reliability.
Trainee
ITC Labs
12.2021 - 07.2022
- Performed analysis of vitamins (A, B, E), mycotoxins, preservatives, synthetic colors, sugars, antioxidants, and amino acids as per standard methods.
- Analyzed vitamins (A, B, E), mycotoxins, preservatives, synthetic colors, sugars, antioxidants, and amino acids per standard methods to ensure product safety and quality.
- Calibrated instruments (HPLC, pH meter, semi-microbalance) and maintained columns, solvents, and mobile phases for optimal performance.
- Compiled analytical test reports and documented laboratory activities to ensure compliance with quality standards.
Education
Master of Science - CHEMISTRY
Goverment Arts College For Mens
Krishnagiri 04.2001 -
B.Ed -
Goverment College of Education
Namakkal, India 04.2001 -
Bachelor of Science - CHEMISTRY
Arignar Anna College(Arts And Sciences)
Krishnagiri 04.2001 -
Bachelor of Science - CHEMISTRY
Arignar Anna College(Arts And Sciences)
Krishnagiri 04.2001 -
Skills
Method validation
Method validation preparation
Quality by Design
Regulatory compliance
Regulatory Compliance
Data Integrity Standards
UPLC-I-Class, HPLC, and GC (Waters Empower, Shimadzu Lab Solutions)
Karl Fischer Auto Titrator (Metrohm – Tiamo software)
Software
EQMS, EDMS,Word and Excel
Interests
Playing cricket and Shuttle
Timeline
Executive Scietist
Syngene International Limited
07.2024 - Current
Executive
Solara Active Pharma Sciences
08.2022 - 05.2024
Trainee
ITC Labs
12.2021 - 07.2022
Master of Science - CHEMISTRY
Goverment Arts College For Mens
04.2001 -
B.Ed -
Goverment College of Education
04.2001 -
Bachelor of Science - CHEMISTRY
Arignar Anna College(Arts And Sciences)
04.2001 -
Bachelor of Science - CHEMISTRY
Arignar Anna College(Arts And Sciences)
04.2001 -
Declaration
I hereby solemnly declare that all statements made above are true and correct to the best of my knowledge and belief.
Strengths
- Ability to Fast Learner & lead a team Juniors.
- Positive attitude, commitment to work, sincerity & punctuality.
- Desire for innovation & continuous learning.
- Training & mentoring juniors