Kandarp Desai

Associate Research Scientist with 16+ years of pharmaceutical industry experience, specializing in Analytical Method Validation for APIs, Intermediates, KSMs, and Raw Materials. Strong expertise in HPLC analysis, Cleaning Validation, Method Transfer, and regulatory-compliant documentation. Extensive exposure to GLP, cGMP, data integrity, instrument qualification, and CSV, supporting global regulatory submissions and inspections.

Associate Research Scientist – Centralized Analytical Method Validation Lab (AMV) - Zydus Lifesciences Limited - Dabhasa - Vadodara, India

(2010-05)

• 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.
• 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.

Executive CQA - Zydus Cadila - Moraiya - Ahmedabad, India

(2009-08 - 2010-04)

Officer - Sun Pharmaceutical Ind. Ltd. - Halol, Gujarat, India

(2006-04 - 2009-08)

Technical Supervisor ADL - Zydus Cadila - Moraiya - Ahmedabad, India

(2005-12 - 2006-04)

Asst. QC Officer - Claria Lifesciences Ltd. - Ahmedabad, India

(2005-05 - 2005-12)

QC Chemist - Rubamin Ltd. - Halol, India

(2004-08 - 2005-05)

Trainee Asst. Chemist - Gujarat Fluorochemicals Ltd. - Ranjitnagar, India

(2003-08 - 2004-09)

Master in Science - Chemistry - Madurai Kamara University (2008)

Bachelor in Science - Chemistry - Gujarat University (2001-06)

H.S.C. - Science - GHSEB (1997-06)

S.S.C. - General - GSEB (1995-06)