Yogesh Sharma
Chandigarh
Summary
Results-driven Senior Solution Consultant with 7 years of experience implementing and supporting enterprise Quality Management Systems (eQMS) in Life Sciences and Pharmaceuticals. Expertise in TrackWise On-Premise, TrackWise Digital, and ComplianceQuest, providing compliant quality solutions. Skilled in CAPA, Change Control, Investigations, Audits, and Regulatory processes, with a solid understanding of FDA regulations and Agile methodologies.
Overview
3
3
Certifications
8
8
years of professional experience
Work History
System Analyst
Hexaware Technologies
Noida
10.2025 - Current
- Administer and support enterprise TrackWise Digital implementation for global pharmaceutical customers.
- Gather business requirements and prepare Functional Requirement Specifications (FRS).
- Collected business requirements and developed Functional Requirement Specifications (FRS) to align with stakeholder needs.
- Configure workflows, forms, layouts, business rules, notifications, dashboards, reports, and security settings.
- Support end-to-end Quality Management processes including: CAPA, Change Control, Non-Conformance Events (NCE), Complaints, Audit Management, Supplier Quality, Document Management, Training Management.
- Perform impact assessments for enhancement requests and TrackWise Digital upgrades.
- Coordinated validation activities for URS, FRS, IQ, OQ, PQ, and UAT to ensure compliance and system integrity.
- Diagnosed production issues and executed root cause analysis to facilitate timely resolutions.
- Collaborate with cross-functional teams including Quality, Regulatory, Manufacturing, Validation, and Business stakeholders.
- Ensure compliance with FDA 21 CFR Part 11, GxP, and Computer System Validation (CSV) guidelines.
Senior Solution Consultant
ComplianceQuest
Noida
06.2022 - 09.2025
- Led multiple ComplianceQuest implementations for global pharmaceutical customers across the US and Europe.
- Conducted workshops, gathered business requirements, and translated them into scalable system solutions.
- Configured and supported various management systems including CAPA and non-conformance to ensure compliance across operations.
- Configured Salesforce Flows, Validation Rules, Security, Reports, Dashboards, Apex, and Lightning Components.
- Led ComplianceQuest platform upgrades from Version 11 to Version 15.
- Performed impact assessments and resolved upgrade-related issues.
- Managed metadata deployment processes using Bitbucket, Workbench, and Change Sets to streamline version control and improve deployment accuracy.
- Supported production deployments, regression testing, and post-Go-Live activities.
- Conducted UAT sessions and user training for business teams to enhance user adoption and ensure system alignment with business needs.
- Worked with global stakeholders throughout implementation and support lifecycle.
Associate – Projects (TrackWise)
Cognizant
Pune
08.2021 - 06.2022
- Configured TrackWise workflows for CAPA, Change Control, Deviations, Investigations, Complaints, Audit, Action Items, and Effectiveness Check modules to streamline compliance processes.
- Configured PR Tasks, workflow states, notifications, and workflow automation.
- Created Process Groups, Projects, User Groups, Divisions, and Memberships to enhance user collaboration and project organization.
- Designed and configured Config Forms and Intelligent Forms.
- Developed Dynamic Queries, Admin Queries, Admin Activities, and Notifications.
- Created and deployed Crystal Reports using Report Application Server (RAS).
- Created Process Groups, Projects, User Groups, Divisions, and Memberships.
- Used Config Migrator for migration across Development, Validation, and Production environments.
- Worked extensively with Team Access and Web Admin.
- Worked with PR Import, Person Import, and Selection Import utilities.
- Performed Unit Testing, Functional Testing, and User Acceptance Testing.
- Supported IQ, OQ, and production validation activities.
- Supported production deployments and post-Go-Live stabilization.
- Investigated and resolved critical production incidents, ensuring compliance with SLA and minimizing downtime.
- Supported TrackWise performance improvements and workflow enhancements.
Consultant – TrackWise
Impact Systems Pvt. Ltd.
Pune
08.2020 - 08.2021
- Configured TrackWise workflows and quality processes to align with business requirements and improve operational efficiency.
- Developed Config Forms and Intelligent Forms to streamline data entry and enhance user experience.
- Gathered requirements and implemented enhancement requests.
- Developed Config Forms and Intelligent Forms.
- Developed Crystal Reports for operational and compliance reporting.
- Oversaw production release coordination and post-Go-Live support.
- Gathered requirements and implemented enhancement requests to support continuous improvement of TrackWise functionality.
Software Engineer
CS Soft Solutions
Chandigarh
08.2018 - 08.2020
- Provided L2/L3 production support for TrackWise applications.
- Managed incident, problem, and service request tickets to ensure timely resolution and minimize service disruptions.
- Configured workflows, users, and security protocols to enhance business processes and improve system efficiency.
- Managed PR Import, Person Import, and Selection Import utilities.
- Developed and deployed Crystal Reports.
- Supported Config Migrator deployments across environments.
- Coordinated production releases and configuration migrations to ensure seamless transitions and maintain system integrity.
- Worked closely with business users to resolve production issues within SLA.
Education
Bachelor of Technology - Chemical Engineering
Deenbandhu Chhotu Ram University of Science And Technology
Haryana, India07-2017
Skills
- TrackWise administration
- TrackWise Digital (Salesforce Platform)
- ComplianceQuest Implementation
- Workflow automation
- Business analysis
- Release management
- Validation processes
- Change control
- Incident management
- User training
- Operational support
- Agile methodology
- Crystal Reports Development
- Crystal Reports
- Reports dashboards
- Workflow Configuration
- Dynamic Queries
- Admin Queries
- Security Configuration
- Validation testing
- Compliance management
- Change Management
- Audit Management
- CAPA
- Non-Conformance
- Complaints
- Supplier Management
- Document Management
- PLM
- Salesforce management
- Data transfer
- Process Groups
- Projects
- PR Tasks
- Team Access
- Web Admin
- Config Migrator
- Config Forms
- Intelligent Forms
- Notifications
- Coordinator Services
- User & Person Management
- PR Import Utility
- Person Import Utility
- Selection Import Utility
- Structured Query Language
- SOQL
- Tools
- JIRA
- Clarizen
- Microsoft Office
- Training oversight
- Flow
- Business Rules
- Workflow Automation
- Flow
- Validation criteria
- SOQL
- Tools
- JIRA
- Clarizen
- Microsoft Office
Certification
Salesforce Certified Administrator
Timeline
System Analyst
Hexaware Technologies
10.2025 - Current
Senior Solution Consultant
ComplianceQuest
06.2022 - 09.2025
Associate – Projects (TrackWise)
Cognizant
08.2021 - 06.2022
Consultant – TrackWise
Impact Systems Pvt. Ltd.
08.2020 - 08.2021
Software Engineer
CS Soft Solutions
08.2018 - 08.2020
Bachelor of Technology - Chemical Engineering
Deenbandhu Chhotu Ram University of Science And Technology