Harshil Gorasia

Excellence in validation of software, computer systems, QC laboratory instruments, and SCADA as per 21 CFR Part 11 and cGMP requirements. Successfully completed CSV projects for different global pharmaceutical clients. Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines, with expertise in writing up and executing test scripts and the complete validation lifecycle from User Requirements Specification (URS) through Validation Summary Reports (VSR).

Proficient in risk assessments, User Acceptance Testing (UAT), IQ/OQ/PQ execution, data integrity assurance, and audit preparedness. Knowledge of IT support-related activities (User Management, Data Backup and Restoration).

Senior Validation Engineering - Cimcon Infotech Pvt. Ltd.

(2024-09)

• Authoring and execution of end-to-end validation documentation and test protocols, including URS, Risk Assessments, Design Specification (DS), Test Scripts (IQ/OQ/PQ), and Validation Summary Reports in compliance with GxP standards.
• Performed spreadsheet validation per US FDA 21 CFR Part 11 and GAMP 5, ensuring data integrity and audit traceability across regulated systems.
• Utilizing Jira for tracking requirements, managing test cases, logging and resolving defects, and monitoring project progress throughout the Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC) phases.
• Performed manual testing like Positive & Negative Testing, Regression Testing, along with defect tracking and reporting to ensure system functionality and quality.
• Investigated and resolved validation issues escalated by QA, pre-sales, and support teams.
• Collaborated with cross-functional stakeholders (IT, Tester, Developers) to support project milestones, regulatory submissions, and product improvement initiatives.

Senior CSV - Engineering - Vedant Tech Services

(2021-11 - 2024-08)

• Led multiple CSV projects end-to-end, ensuring on-time delivery and full regulatory & IT compliance with GxP, GAMP 5 guidelines, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles.
• Responsible for Preparation, Review and Execution of Computer System Validation activities at different Pharmaceutical Companies.
• Hands-on experience in validating PLC-HMI, PLC-IPC/SCADA, BMS, EMS, and analytical laboratory software applications. Proven expertise in the validation of pharmaceutical manufacturing systems, including OSD production, injectable manufacturing processes, packaging line systems, and QC systems, ensuring compliance with regulatory and GxP requirements.
• Documented knowledge of IRA, VP, URS, FS, DS, FRA, IQ, OQ, PQ, RTM, and VSR for validation processes.
• Performed IT related supporting activities (User Management, Data Backup and Restoration, System Remote Setup).

BE - Instrumentation & Control - Vishwakarma Government Engineering College, Gandhinagar (2021)

Diploma - Instrumentation & Control - Government Polytechnic, Gandhinagar (2018)