• Conducted validation and testing of software solutions, including Smart Solve and RIM Smart, as a Consultant at IQVIA, ensuring regulatory compliance and software reliability.• Developed comprehensive Computer System Validation (CSV) documentation, including System Certification, Test Plans, Test Scripts, and Test Summary Reports to ensure software compliance with industry standards.• Collaborated with Business Analysts and System Owners to analyze User Requirements Specifications… Show more • Conducted validation and testing of software solutions, including Smart Solve and RIM Smart, as a Consultant at IQVIA, ensuring regulatory compliance and software reliability.• Developed comprehensive Computer System Validation (CSV) documentation, including System Certification, Test Plans, Test Scripts, and Test Summary Reports to ensure software compliance with industry standards.• Collaborated with Business Analysts and System Owners to analyze User Requirements Specifications (URS) and integrate compliance requirements into the validation process.• Reviewed and approved Installation Qualification (IQ) and Performance Qualification (PQ) test scripts; managed deviations during software qualification and data migration to ensure project integrity.• Collaborated with cross-functional project teams to define and implement validation strategies, providing expert guidance throughout the project lifecycle.• Reviewed and approved both manual and automated test scripts, test logs, and traceability matrices to ensure thorough validation and compliance with requirements.• Executed software testing for client deliverables, developed CRP (Conference Room Pilot) scripts and PQ (Performance Qualification) scripts, ensuring comprehensive validation of Business Requirements Documents (BRD) prior to client handover. Show less

• Led data governance activities, including periodic system application reviews, audit trail analysis, data backup restoration, and V-model validation for server, cloud, and standalone systems.• Managed computer system validations (URS, SAT, FAT, IQ, OQ, PQ, etc.) in compliance with 21 CFR Part 11, GAMP 5, and EU Annex 11 using Val Genesis (eVLMS).• Developed and implemented risk-based validation strategies, including testing, documentation, and version release protocols.• Reviewed… Show more • Led data governance activities, including periodic system application reviews, audit trail analysis, data backup restoration, and V-model validation for server, cloud, and standalone systems.• Managed computer system validations (URS, SAT, FAT, IQ, OQ, PQ, etc.) in compliance with 21 CFR Part 11, GAMP 5, and EU Annex 11 using Val Genesis (eVLMS).• Developed and implemented risk-based validation strategies, including testing, documentation, and version release protocols.• Reviewed and managed deviations, investigations, CAPA, and change control processes related to system qualification using QMS (TrackWise).• Implemented ALCOA+ quality principles throughout the product development process to ensure data integrity and compliance. Show less

• Executed CSV activities (URS, DS/DQ, IQ, OQ, PQ, etc.) in compliance with 21 CFR Part 11, GAMP 5, Annex 11 using Validator.• Conducted Periodic performance verifications and prepared qualification summary reports for equipment and applications.• Managed lab implementation projects, coordinating with stakeholders to ensure timely completion.• Ensured timely calibration and qualification of instruments and applications in the analytical lab.• Managed change control and… Show more • Executed CSV activities (URS, DS/DQ, IQ, OQ, PQ, etc.) in compliance with 21 CFR Part 11, GAMP 5, Annex 11 using Validator.• Conducted Periodic performance verifications and prepared qualification summary reports for equipment and applications.• Managed lab implementation projects, coordinating with stakeholders to ensure timely completion.• Ensured timely calibration and qualification of instruments and applications in the analytical lab.• Managed change control and discrepancies in QMS for new system applications and SOPs.• Tested software for bugs and functionality using TestRail, ensuring high-quality performance before release. Show less

• Executed CSV activities (URS, DS/DQ, IQ, OQ, PQ, etc.) in compliance with 21 CFR Part 11, GAMP 5, Annex 11 using Validator.• Conducted Periodic performance verifications and prepared qualification summary reports for equipment and applications.• Managed lab implementation projects, coordinating with stakeholders to ensure timely completion.• Ensured timely calibration and qualification of instruments and applications in the analytical lab.• Managed change control and… Show more • Executed CSV activities (URS, DS/DQ, IQ, OQ, PQ, etc.) in compliance with 21 CFR Part 11, GAMP 5, Annex 11 using Validator.• Conducted Periodic performance verifications and prepared qualification summary reports for equipment and applications.• Managed lab implementation projects, coordinating with stakeholders to ensure timely completion.• Ensured timely calibration and qualification of instruments and applications in the analytical lab.• Managed change control and discrepancies in QMS for new system applications and SOPs.• Tested software for bugs and functionality using TestRail, ensuring high-quality performance before release. Show less

• Manage the qualification of newly purchased instruments, ensuring they meet regulatory standards.• Prepare and execute test scripts for software and hardware validation, including Performance Qualification (PQ), Audit Trail (AT), and Electronic Records and Signatures (ERES) to comply with 21 CFR Part 11 and Annex 11 guidelines.• Oversee the calibration, preventive maintenance, and servicing of instruments to maintain compliance and optimal performance.

• Responsible for qualifying and verifying both GxP and non-GxP instruments to ensure compliance with regulatory standards prior to their use in the laboratory.• Ensured on-time calibration and qualification of instruments and their applications in the lab.• Coordinate with respective department at the time of internal, external and regulatory audits.• Review of SOP, Master BMR, Raw analytical reports and Artwork.

• Chemical and instrument analysis of different varieties of wheat.• Documentation and trend analysis of wheat quality and preparation of annual report on wheat variety and its quality grown in various parts of India.• Training in Good laboratory practice, good manufacture practice and Environmental health and safety.