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Post : Senior Manager, Vault Quality Technical Analyst
Job Description
Role Overview
• Act as a liaison between Quality Operations, IT, and business stakeholders to gather, analyze, and document requirements related to Veeva Vault Quality applications.
• Drive process improvements and system enhancements to optimize the use of Veeva Vault for Quality Management.
• Support the implementation and ongoing maintenance of Veeva Vault Quality modules aligned with regulatory and business needs.
Key Responsibilities
• Collaborate with Quality, Compliance, and IT teams to understand business processes and translate them into system requirements for Veeva Vault Quality Operations.
• Gather, analyze, document, and validate comprehensive business and functional requirements to support system enhancements, upgrades, and new implementations.
• Analyze current Quality Operations workflows (e.g., QualityDocs, QMS, Audit, Issues, Inspections, Complaints, Change Control) and identify opportunities for automation or process improvement using Veeva Vault.
• Support configuration and testing activities by creating test plans, test cases, and coordinating User Acceptance Testing (UAT).
• Facilitate communication between technical teams (developers, administrators) and business users to ensure clear understanding of requirements and solutions.
• Assist in change management activities including training material development, user guides, and conducting training sessions.
• Monitor system performance and user feedback to recommend continuous improvements.
• Ensure compliance with regulatory standards (FDA 21 CFR Part 11, GxP) in all system-related processes.
• Maintain documentation such as business process maps, requirement specifications, and SOPs related to Veeva Vault Quality Operations.
Candidate Profile
• 4+ years of Technical Analyst experience with Vault Quality Systems (QualityDocs, QMS)
• Strong understanding of Quality processes including CAPA, Change Control, Document Management, Complaints and Audits.
• Experience gathering and documenting business and functional requirements.
• Familiarity with system validation lifecycle and testing methodologies.
• Experience using JIRA/XRAY for test case management, test execution, reporting, defect management within Agile environments.
• Excellent communication and stakeholder management skills.
• Ability to translate complex business needs into clear technical requirements.
• Knowledge of regulatory requirements in pharmaceutical, biotech, or medical device industries.
• Proficiency with process mapping and documentation tools.
• Detail-oriented with strong analytical and problem-solving skills.
Preferred Qualifications
• Experience working directly with Veeva Vault or other cloud-based QMS platforms.
• Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date
• Background in regulated environments (pharma, biotech, medical devices).
• Experience with Agile or other software development methodologies.
• Familiarity with reporting and data analysis tools.
Additional Information
Experience : 4+ years
Location : Hyderabad, Telangana
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Vault Quality Technical Analyst
End Date : 31st October 2025
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