Aurigene Pharmaceutical Services

2 weeks ago

Hyderabad, Telangana, India Aurigene Pharmaceutical Services Limited Full time ₹ 6,00,000 - ₹ 12,00,000 per year

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

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