Subham Gorai
Veeva Technical Lead
Summary
Veeva Vault and ECM Document Consultant with over 10 years of specialized experience in the Life Sciences sector, focusing on quality and regulatory compliance. Proven expertise in the Veeva Vault Quality Suite, including document management, GxP compliance, validation, and comprehensive incident, problem, and change management. Demonstrated ability to provide production support, manage releases, coordinate with vendors, and facilitate knowledge transitions in diverse global environments. Committed to leveraging extensive ECM skills within the Life Sciences and pharmaceutical industries to drive impactful solutions and enhance operational efficiency.
Overview
1
1
Certification
3
3
Languages
Work History
Team Lead
Capgemini
- Extensive experience working on Veeva Vault for Quality and Regulatory document management.
- Hands-on configuration in Veeva Vault QualityDocs, Veeva Vault QMS
- Configured document types, object types, lifecycles, workflows, security profiles, permission sets, and dynamic access control.
- Managed user roles, security setup, and access troubleshooting aligned with GxP compliance.
- Supported end-to-end document lifecycle from creation, review, approval, effective, to archival.
- Built and maintained workflows for document review/approval, change control, deviations, CAPA, and training assignments.
- Provided L2/L3 production support, incident resolution, and root cause analysis within SLA.
- Coordinated with business users for requirement gathering, UAT support, and release validation.
- Worked on Vault releases, impact assessment, regression testing, and configuration updates.
- Prepared validation documents (URS, FS, RTM, IQ/OQ support) for regulated environments.
- Managed metadata corrections and bulk updates using Vault Loader.
- Experience with reports, dashboards, and audit trail review for compliance audits.
- Created SOPs, KT documents, and user training materials.
- Collaborated with global stakeholders across US/EU time zones during critical releases and hypercare.
Senior Consultant
Capgemini
- Configured and managed D2 environments using D2-Config (configuring types, lifecycles, workflows, naming rules, and UI layouts).
- Administered repositories using Documentum Administrator (DA) and handled jobs, methods, queues, and server configurations.
- Designed and maintained document lifecycles, state transitions, permission sets, and automated workflows.
- Monitored and resolved stuck workflows, job failures, and performance issues.
- Supported validation activities (IQ/OQ/PQ), audit trail verification, and GxP documentation.
- Coordinated with infrastructure teams for server patching, upgrades, and environment refreshes.
- Used ticketing tools like ServiceNow/Remedy for Incident, Problem, and Change Management.
Support Analyst
Cognizant
- Worked extensively on OpenText Documentum for document lifecycle management in GxP-compliant environments.
- Managed document types, lifecycles, workflows, cabinets, folders, and ACL configurations.
- Assisted in workflow configuration, monitoring stuck workflows, and resolving routing issues.
- Monitored and resolved incidents and service requests within SLA using ticketing tools.
- Conducted root cause analysis for recurring issues and implemented preventive actions.
- Assisted in UAT support, requirement gathering, and documentation for enhancements.
- Performed repository health checks and basic admin activities (jobs, methods, queues).
- Coordinated with business users for document archival, version control, and audit trail verification.
- Prepared SOPs, KT documents, and user guides for operational support.
- Participated in validation documentation for GxP systems (IQ/OQ/PQ support).
- Worked with a ticket tool Remedy.
Project Engineer
Wipro
- Provided L2 production support for Documentum Webtop applications.
- Supported regulatory application of Life science domain pharma industry.
- Performed user access management, group creation, and permission troubleshooting using ACLs.
- Supported document migrations, bulk uploads, and metadata corrections using DQL and import tools.
Education
Bachelor of Computer Application (BCA) -
Asansol Engineering College
04.2001 -
Skills
Veeva Vault
Veeva Vault Configuration
Document Management
System Integration
Requirement Gathering
Documentum D2
Webtop
D2LS
QDman
Postman
Certification
Certified Veeva Vault Platform Associate Administrator
Timeline
Bachelor of Computer Application (BCA) -
Asansol Engineering College
04.2001 -
Team Lead
Capgemini
Senior Consultant
Capgemini
Support Analyst
Cognizant
Project Engineer
Wipro