Chandu Kattula

Validation Lead Engineer @Ascendis Pharma

Developed and executed test cases for Argus Pharmacovigilance and HaloPV, Azure DevOps, CTMS, Veeva EDC.• Supporting systems: Veeva EDC, Argus PV, HALO PV, IRT, Pharmacovigilance, and Trial Master EDC systems, P21 Systems.• Validated the end-to-end integration of IRT to CTMS and CTMS to Veeva EDC, developed the Test Cases.• Validated the Clinical Trails integrations and Studies developments.• Reviewed Deviations, Change Controls, CAPA’s Defects, Deviations.• Experience in authoring SOPs, WI’s, Corrective Actions, Defects, Deviations• Assess compliance with established regulatory requirements, GxP guidance, and company policies and procedures.• Authored IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols: Ensured compliance with 21 CFR Part 11 regulations.• Data Integrity verification for Trial Master.• Authored, reviewed, and approved various validation-related documents and protocols for Software as well as hardware systems.• Authored, dry-ran, and executed test cases for Adverse Event cases, Reporting Rules, Advanced Conditions implementations and Workflow & User Permission updates.• Reviewed and approved pre-and post-executed test scripts and ensured they meet the standards.