Configuration Expert Veeva QMS

We are hiring for Couple of Veeva position

Role1: Configuration Expert Veeva QMS

Role2: Business Analyst and Scrum Master Veeva QMS

Role3: Developer Technical Analyst Veeva QMS Systems (Veeva)

Role4: Tester Veeva QMS System

Exp: 8 Years

Location: Pan India

Start Date: ASAP

Job Description:

Specialisation in GxP Quality Document Records and Learning Management Processes

Position Summary

We are seeking an experienced Configuration Expert in Veeva QMS with a strong background in GxPregulated environments The ideal candidate will be responsible for configuring optimising and maintaining Veeva Quality Management System QMS modules specifically focusing on GxP Quality Document Management GxP Quality Records Management and GxP Learning Management Processes Veeva Vault QMS Configuration Expert will be able to design configure validate and govern Veeva QMS processes across Deviations CAPA Change Control Complaints Audits and Training Will lead Vault configuration workflows lifecycles security migrations and VPKbased releasesensuring GxPCSV compliance data integrity and scalable design aligned to global quality processes

Key Responsibilities

Configure Veeva QMS modules to support GxP Quality Document Management Quality Records Management and Learning Management processes

Customise workflows metadata access controls lifecycle states and notifications as per business and regulatory requirements

Manage user roles permissions and security settings to ensure data integrity and compliance

Analyse and document current GxP processes identifying opportunities for optimisation within Veeva QMS

Configure objects fields object relationships lifecycles workflows rolespermissions page layouts and picklists

Implement validation rules formulas conditional visibility and entryexit criteria for lifecycle states

Design role based task routing SLAs escalations and conditional approvals

Lead configuration for DeviationsNon Conformance Investigation CAPA Effectiveness Checks

Configure Change Control impact assessment risk approvals Complaints AuditsFindings and Training assignments linked to QMS outcomes

Standardize global templates support multi sitemulti market processes with controlled variations

Govern DevTestUATProd promotion using Configuration Migration Packages VPKs

Maintain configuration baselines release notes and change logs manage cutovers and smoke tests

Perform impact analysis for quarterly Vault releases plan regression hotfixes

Execute Vault Loader migrations objectsdocuments mapping cleansing and reconciliation

Define data standards and completeness checks resolve load errors and edge cases

Authorreview Config Specs Risk Assessments Test Scripts RTM and release validation evidence IQOQPQ

Ensure alignment with GxP 21 CFR Part 11 EU Annex 11 ALCOA data integrity principles

Support auditsinspections with configuration rationales and traceability artifacts

Ensure all configurations align with global regulatory requirements FDA EMA MHRA etc and company SOPs

Participate in system validation change control and periodic review activities

Work closely with Quality Assurance Compliance IT and business users to gather requirements and deliver effective solutions

Provide subject matter expertise and guidance on Veeva QMS functionalities and best practices

Facilitate user acceptance testing UAT training and golive activities

Monitor system performance and resolve configurationrelated issues in a timely manner

Maintain documentation for configurations workflows and system changes

Stay abreast of Veeva product updates and industry trends recommending continuous improvements

Required Qualifications Experience

58 years handson in Veeva Vault QMS configuration

Proven build experience across multiple QMS modules Deviations CAPA Change Control Complaints Audits

Deep knowledge of Vault lifecycles workflows security model formulas validation rules and object model design

Handson with VPKbased deployments release governance and Vault Loader migrations

Strong understanding of GxP 21 CFR Part 11 EU Annex 11 ALCOA and CSV deliverables

Excellent documentation and communication skills comfort leading workshops and UAT

Experience with multisiteglobal templates-controlled localizations and global process harmonization

Exposure to Vault REST APIs and working with middleware teams MuleSoftBoomi for integrations with ERPLIMSMESLMS

Preferred Skills

Veeva certifications in QMS or Vault platform

Experience with system integrations and data migration in Veeva QMS

Knowledge of broader quality systems CAPA Deviations Audit Management etc

Proven ability to work in a multicultural global team environment

Thanks,

Himabindu