Jai Prabhanshi Varshney

Computer System Validation Lead

Profile Summary

• Overall 11 years of experience in Quality Assurance, Validation of regulated applications in accordance with FDA regulations.
• Responsible to create Validation deliverables - Validation Plans, Risk Assessments, Requirement Specifications, Qualification Protocols, Data Migration Plans, Gap Analysis documents, IQ/OQ/PQ test protocols/scripts in HP ALM, Trace Matrices and Validation/Qualification Summary Reports. 
• Worked in Validation of Systech Serialization System (Sentri, Advisor and Guardian) as per DSCSA (Drug Supply Chain Security Act) Part 52 to meet worldwide Track and Trace requirement.
• Worked in Validation of Veeva Vault- Registrations and Archive Module, Document Management system, Submission Publishing System, Drug Labelling Management, Agile Product Lifecycle Management System, Electronic Document Management System (EDMS), Excel spreadsheets, Oracle Applications R11, Siemens Enterprise Product Lifecycle Management System, and Argus Safety Management.
• Extensive experience in writing SQA leverage acceptance report following CSA approach for validation.
• Extensive experience in Disaster Recovery Qualification testing for GxP systems.
• Extensive experience in analyzing Business Requirements and Software Requirement Specifications to develop User Test Specification and Functional Test Specification.
• Extensive experience in validating various software applications in accordance with GxP regulations.
• Extensive experience in Change Control process in reviewing and approving change tickets within Trackwise and Veeva Vault Quality Management System.
• Expertise in developing Validation Plan, Validation Summary Reports and Traceability Matrix.
• Excellent knowledge of testing methodologies, strategies, and Software Development Life Cycle (SDLC) methodology.
• Extensive experience in documentation such as writing Master Test Plan, Test cases for various GxP regulated applications.
• Experience in writing Deviations and CAPAs and coordinating their review and approval with Quality Assurance, System Manager and Business Process Owner.
• Expertise in Software Quality Assurance, including system analysis, systems design, documentation, implementation, and integration of project management systems on various platforms.
• Working knowledge of FDA regulations and GxP (GCP/GLP/GMP) guidelines.
• Extensive work experience with 21 CFR Part 11 and audit trail validation process.
• Experience in executing software validation protocols (IQ, OQ, and PQ).
• Excellent working knowledge in HP ALM.

Leadership qualities with emphasis on individual and team effort backed by good communication skills.

Education:

Bachelor Of Technology (2007)

Computer Science &Engineering

Uttar Pradesh Technical University

Certifications:

1. ISTQB- CTFL (Nov-2024)
2. Microsoft Certified Application Developer (Sep-2008)
3. Microsoft Certified Technology Specialist (Nov-2008)

Technical skills

• Validation: FDA Regulations 21 CFR Part (11, 50, 56, 210, 211, 820), cGxP(cGMP, cGCP, cGLP, cGDP), GAMP, IQ, OQ, PQ, SOP’s, LIMS, VSR, VMP, GAP Analysis, CAPA, Deviation, RTM, Audit Trails, Periodic Reviews
• Other Tools/Software: MS Office, MS Visio, MS Project, TrackWise, Veeva Vault, Documentum (First Doc), LIMS, Kaye Validator 2000, SharePoint, HP ALM