Quality Control, Analytical Method Validation
Highly motivated and detail-oriented chemist with five years of experience in analytical chemistry. Skilled at conducting chemical analysis using extensive knowledge of analytical methods. Proficient at maintaining and troubleshooting laboratory equipment
Ø Method Validation analysis and Protocols and Report preparation, Stability sample analysis and stability trend summery preparation
Ø Routine analysis of finish product as per EP,IP,BP,USP by using GC, HPLC, UV-Vis spectroscope and preparation of Analytical Test Reports.
Ø Testing of water samples by using pH meter, TDS, Conductivity meter, Handling of Reference standards.
Ø To qualified working Standard against primary standards.
Ø Preparation and standardization of volumetric solution.
Ø Calibration of Instruments GC, HPLC, UV spectroscope, pH meter, Analytical Balance, Karl fisher.
Ø Daily monitoring of temperature and humidity of the chemical lab, sample retention room and stability chamber and maintaining record.
Ø Check the expiry of lab chemicals and ensure the require materials or chemicals are available in QC lab according to the needs.
Ø Managing data generated by analytical instruments.
Ø Good Documentation of each trial and routine analysis.
Ø Investigation and Closing of change control and deviation.
Ø Trouble shooting in routine analysis.
Ø Following GLP and GMP Practices as per Regulatory requirements.
Ø Awareness of regulatory requirements, basic knowledge of audit documentation
Ø To face WHO, German FDA,USFDA, Internal audit and Customer audits.
Ø Knowledge about 21 CFR part with data integrity.
ØAdapted standard methods and procedures to solve analytical problems.
ØLearned and adapted quickly to new technology and software applications.
Chemistry, Gas Chromatography, HPLC, UV-vis Spectroscope, GMP
Quality Control, Analytical Method Validation
Admin work Stock Market analysis, Reading news paper, Books