Job Description

Central Validation Lab: Executive / Sr Executive Experience : 3-7 yrs CVL-HPLC/GC Analyst: Perform analysis related to analytical method validation, cleaning validation, forced degradation study, pharmacopoeial evaluation for API. Preparing method validation protocols and reports. Perform method transfer activity. Thorough knowledge of RS, Assay, Residual solvent and PSD method validation as per ICH guidelines. Expert in handling and calibration of instruments such as HPLC, GC, Malvern Particle Size analyzer, UV, KF, IR and other lab instruments. Aware of cGMP practices, must follow and maintain GLP. CVL-Reviewer: Thorough knowledge of RS, Assay, Residual solvent and PSD method validation as per ICH guidelines. Expert in analytical raw data review for method validation, method transfer and instrument calibration. Aware of cGMP practices, must follow and maintain GLP. Experience of GLP activities such as instrument installation and qualification. Knowledge of regulatory requirements. Knowledge of chromatographic software Empower 3. Able to maintain all Lab records, logbooks, calibration data, SOPs, training records etc.