Kandarp Kumar Desai

• Independently handling Analytical Method Validation for Assay, Related Substances, Residual Solvents.
• Autotitrator, Carry-Over Studies, Cleaning Validation.
• Genotoxic Impurities of RM, KSM, Intermediates, and APIs using HPLC.
• Review and support Analytical Method Development for Key Starting Materials, In-Process Samples, Intermediates, APIs.
• Preparation, review, and approval of protocols and validation reports for regulatory submissions.
• Execution of method transfer activities to multiple manufacturing locations.
• CURRENT AREA OF EXPOSURE:
• Handling complete GLP and cGMP documentation, including: Change Controls, Deviations, CAPA.
• Investigation and closure of laboratory incidents, deviations, and change controls.
• Preparation, revision, and implementation of SOPs as per regulatory updates.
• Investigation, root cause analysis and trending of: Laboratory incidents, Out of Calibration (OOC) events.
• Audit trail review of all computerized systems.
• Equipment IQ/OQ/PQ qualification.
• Calibration and preventive maintenance as per schedule.
• Handling and review of CSV Master Plan (CSVMP) for all GxP software.
• Perform the self-inspection of QC, PD Lab and IT department.
• Compliance of Self-Inspection of Validation cell department.
• Department training coordinator and provide training to all other employees.

GPA: 52.55%

GPA: 44.31%

GPA: 77.43%