Aurigene Pharmaceutical Services - Veeva Vault Techno-Functional Consultant

Responsibilities

• Lead and execute the implementation, configuration, and deployment of Veeva Vault applications (QMS, eQMS, RIMS, or QualityDocs).
• Configure Vault objects, lifecycles, workflows, security settings, and metadata to align with business processes.
• Support system validation activities, including URS, FRS, IQ/OQ/PQ documentation.
• Collaborate with Veeva support and internal IT teams for environment setup, user management, and release management.
• Participate in system upgrades, patching, and release testing to ensure seamless Analysis & Requirement Gathering :
• Engage with business stakeholders to capture, document, and analyze business requirements for quality and regulatory processes.
• Translate business needs into functional and technical specifications for configuration and development.
• Recommend system and process enhancements aligned with best practices and regulatory compliance (GxP, 21 CFR Part 11).
• Act as a bridge between business users, QA, IT, and development teams to ensure clarity and alignment.
  

Support, Maintenance & Troubleshooting

• Provide Level 2/3 functional and technical support for Veeva Vault applications.
• Investigate and resolve configuration issues, data integrity challenges, and workflow errors.
• Conduct root cause analysis and implement corrective/preventive actions (CAPA) for recurring system issues.
• Manage user access, roles, and security privileges within Veeva Vault.
  

Process Documentation & Compliance

• Prepare and maintain process documentation, including SOPs, configuration guides, validation deliverables, and change control logs.
• Ensure all implementations are compliant with GxP, FDA, EMA, and ISO regulatory standards.
• Assist in audits, inspections, and internal quality reviews by providing system documentation and evidence.
  

Stakeholder Management & Collaboration

• Work closely with Quality, Regulatory, and IT teams to ensure solution alignment with business goals.
• Conduct user training, demos, and UAT sessions for new features or releases.
• Communicate system enhancements, issue resolutions, and release impacts to relevant stakeholders.
• Coordinate with Veeva Support for issue resolution and environment updates.
  

Required Qualifications & Skills

• Bachelors or Masters degree in Computer Science, Information Technology, Life Sciences, or a related discipline.
• 4- 6 years of hands-on experience in Veeva Vault implementation and support (preferably QMS, eQMS, RIMS, or QualityDocs).
• Strong techno-functional expertise ability to configure, test, and validate Vault applications while understanding underlying business processes.
• Experience in Veeva Vault administrative configuration objects, lifecycles, workflows, security, and reports.
• Working knowledge of GxP validation requirements, change management, and 21 CFR Part 11 compliance.
• Exposure to document control systems, CAPA, training management, or regulatory submissions workflows.
• Proficiency in process mapping, requirement documentation, and UAT coordination.
• Familiarity with SQL, XML, APIs, or other integration technologies is an added advantage.
• Excellent analytical, problem-solving, and communication skills.
  

Preferred Qualifications

• Experience in Life Sciences, Pharmaceuticals, Biotechnology, or Medical Devices industry.
• Veeva Vault Administrator or Veeva Certified Professional certification.
• Experience with Quality Systems (QMS/eQMS) and Regulatory systems (RIMS, QualityDocs).
• Understanding of GMP, GCP, GLP, and other quality standards.
• Hands-on experience in end-to-end system validation and data migration