Role Description:
Good understanding of Quality processes, including Deviations, CAPA, Lab Investigations, Change Control, Audits, Complaints, and Training.
Application Support (Incident, Problem, Change Management)
Excellent stakeholder management and communication skills with the ability to interact effectively with business and technical teams.
SN Responsibility of Expectations from the Role
Serve as the primary point of contact for business users regarding Veeva QMS application issues, service requests, and system inquiries.
Provide L3 support and administration for Veeva QMS
Monitor, troubleshoot, and resolve incidents, defects, and production issues within agreed SLA timelines.
Perform root cause analysis for recurring issues and implement corrective and preventive actions.
Manage user access, security roles, permissions, and system configurations in accordance with company policies and compliance requirements.
Support Veeva Vault releases by performing impact assessments, regression testing, validation support, and deployment activities.
Coordinate with Veeva Support, vendors, and internal IT teams to resolve complex technical issues.
Maintain application documentation, knowledge articles, support procedures, and system configuration records.
Support data management activities, including data corrections, bulk updates, and migration-related tasks as required.
Participate in change management processes, including impact analysis, testing, implementation, and post-deployment support.
Collaborate with Quality, Regulatory, Validation, and Business teams to understand support needs and drive continuous improvements
Familiarity with IT processes and tools such as ServiceNow, HPALM, and JIRA.
Good understanding of Active Directory and Citrix applications.
GxP Awareness including Good documentation Practice
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