Kindeva Drug Delivery

General

• Administer Veeva Vault Documents, Training, and Quality Management System modules
• Maintain user accounts, roles, groups, permissions, and access requests
• Assist with configuration of document types, metadata, workflows, lifecycle states, templates, vocabularies, roles, and permissions
• Provide first-line user support, triage issues, document incidents, and escalate complex items
• Support controlled document routing, workflow troubleshooting, version control, issuance, archiving, and metadata quality checks
• Create and update work instructions, quick reference guides, training materials, job aids, and support communications
• Assist with reports, dashboards, metrics, and data extracts
• Participate in change control, testing, approvals, and controlled implementation
• Translate cross-functional requirements into system solutions
• Support Change Control, CAPA, Deviations, Complaints, and Document Management processes
• Establish and maintain global templates for SOPs, forms, documentation management, and quality system modules
• Lead or participate in governance forums, quality councils, and harmonization initiatives
• Support Veeva Vault releases, regression testing, defect documentation, and deployment readiness
• Support validation and compliance deliverables, including test cases, evidence capture, traceability, and system documentation
• Collaborate with Quality, IT, Validation, Training, Document Control, Engineering, Automation, HR, and business stakeholders
• Ensure data integrity, backup, and disaster recovery protocols
• Monitor system logs and security alerts and implement corrective actions

Senior Veeva Vault System Specialist

System Administrator

• Administer and configure the Kneat eValidation system across all Kindeva sites
• Create, update, and maintain Kneat templates, workspaces, disciplines, document types, and document packs
• Manage user accounts, roles, access modifications, and periodic access reviews
• Execute and document validation lifecycle activities including IQ/OQ/PQ, protocol execution, discrepancy management, and summary reports
• Provide end-user support and troubleshoot Kneat configuration, document routing, and execution issues
• Support system release updates through release-note review, validation impact assessments, regression testing, and documentation
• Collaborate with Quality, IT, Engineering, Manufacturing, and other cross-functional teams
• Assist with user training and onboarding
• Support inspection readiness by maintaining complete and accurate records, audit trails, and system documentation
• Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and applicable regulations
• Support Change Control, CAPA, Deviations, Complaints, and Document Management processes
• Participate in governance meetings and harmonization initiatives
• Coordinate and execute release testing, including drafting test cases and owning associated change controls
• Monitor system performance, logs, and security alerts; troubleshoot issues and implement corrective actions
• Maintain configuration and validation documentation
• Ensure data integrity, backup, and disaster recovery protocols are in place

Senior Veeva Vault System Specialist

Validation Systems Administrator