Aurigene Pharmaceutical Services - Veeva Vault Techno-Functional Consultant

Description:

Key Responsibilities :

System Implementation & Configuration :

- 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 functionality.

Business 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