Najaruddin Navlekar

Background

About Najaruddin Navlekar

I have been involving various works in Q.C. Department Analysis of Raw Material, Intermediate and Inprocess Sample. Calibration of Instruments. Preparation of Specification & Test Data Sheet. Preparation of Protocol. Preparation of SOP & Calibration format. Record of Working standard, Documentation as per cGMP. To ensure that all necessary testing is carried out. To check the maintenance & up clean of Q.C. department, premises and equipments. Ensure that the appropriate validation are done. Ensure that the required initial and continuing training of department as personnel is Carried out and adopted according to need Reviewing validation protocols and reports Perform Analytical Method Validation of Residual Solvents on Head Space Analyser as per ICH guideline (Q2B). Perform Analytical Method Validation of Releated Substance & Assay on HPLC as per ICH guideline (Q2B). Perform Forced Degradation study. Analytical Method Validation on Automatic Potentiometric Titrator. Perform Method Development work Handling of change controls, Deviations. Distribute work to individuals as allocated in work distribution register. To allocate the work in detail in work distribution register for Quality Control staff according their knowledge about the work. Planning & Monitoring testing for starting material, In process and finished materials. Preparation, updating & presentation of various documents in Q.C. laboratories. Stability Study perform as per ICH Guide Line Q1A(R2). & Q1B To monitor stability programme Preparation for facing inspection of international authority like USFDA, WHO & various Customer audits. Specialties: Method Development & Method Validation