Aurigene Pharmaceutical Services

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 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 (ref:hirist.tech)