eQMS Validation Analyst/Tester

5 days ago

Bengaluru, Karnataka, India Disa Consulting Services Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Experience: 5+ Years

Location: Pan India / Remote

Comment: Veeva Quality Vault experience and experience with ADLC and toolsets (QTEST, Tosca, Atlassian)

Description::

  • This role will be responsible for developing and maintaining solution architecture, system administration, security, and procedures across the Veeva Vault Platform.
  • Support all assigned development activities for the Veeva Vault implementation program under the leadership of the client Quality Veeva team.
  • Coordinate with Business analysts to outline the business requirements and ensure IT security and Data Integrity requirements are outlined for the solution
  • Coordinate with Validation team to prepare the Regulatory Applicability Assessment and Regulatory Risk Assessment documents
  • Document specifications and user stories
  • Conduct technical feasibility analysis of requirements
  • Document System design or configuration specifications document
  • Perform Veeva environment management
  • Develop custom solutions and integrations to automate workflows, enhance system capabilities, and ensure seamless integration with third-party applications.

Required skills:

  • Experience with Configuration and Customization: Setting up and customizing Veeva Vault applications to meet client-specific requirements.
  • Experience with Veeva Vault Quality, with a strong emphasis on QMS/QualityDocs experience; documented certification and experience in a GxP environment is highly preferred.
  • Experience with developing custom solutions and integrations to automate workflows, enhance system capabilities, and ensure seamless integration with third-party.
  • Development and Implementation: Building and deploying solutions using Veeva Vault functionalities, including workflows, metadata structures, and security settings.
  • Integration: Developing and managing integrations between Veeva Vault and other enterprise systems (e.g., SAP, Salesforce) using technologies like APIs, SOAP, and REST.
  • Proficiency in relevant technologies like XML, SQL, APIs, and programming languages like Java and JavaScript
  • Proven development of cloud-based solutions
  • Familiar with SDLC and the delivery of GxP Validated systems
  • Veeva QMS certification is a big bonus

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