Job Title

Job title Senior Specialist Technical Operations Veeva VaultReports to Operation Head – India Job purpose Senior Veeva Vault professional with extensive experience in Veeva Vault configuration, implementation, and administration across global projects. Expertise in implementing and supporting multiple Vault applications including Clinical Vaults( eTMF,CTMS,RTSM) and Quality (QMS). Development with hands-on experience in both Classic and Lightning platforms. Proven ability to manage deployments, package migrations, and system validations in production environments. The candidate should also be experienced in CSV related to Veeva Application with knowledge on CSV requirements as per FDA and EMA.This position is in Hyderabad, Telangana, India. Duties and responsibilities Work on different Veeva configuration and operations related to clinical vaults related to user management, lifecycle management, workflow management & have knowledge on working in lower environment and validation activities.Should work on governance-level administration, access control strategy, release management, and compliance oversight.Should work on clinical business functionality with GxP contextual application and clinical domain knowledge.Should work on Global Veeva Vault Project Implementation, Vault Deployment & Release Management Package Migration & Validation, Production Environment Deployments.Should work on validation strategies and related activities with articulation of the end-to-end lifecycle, including risk-based validation strategy, traceability, and compliance documentation expectationsWork on the governance and procedure lifecycles with the understanding of SOP lifecycle integration with system validation and IT QA oversight.Evaluate Veeva general releases, conduct assessments/proof of concepts (POCs), and develop business cases for implementing new enhancements or configurations to align with enterprise needsLead and oversee change controls, manage system deviations, and drive continuous improvement initiatives. Ensure all activities are performed in accordance with defined GxP processes and are appropriately documented to maintain compliance.Ensure critical system operations activities—such as access management, periodic reviews, configuration updates, and data integrity monitoring—are performed in compliance with established GxP procedures and operational standards.Work with the business to develop document system and user requirements aligned with GxP principles and 21 CFR Part 11 compliance.Define and oversee documentation of configuration and design specifications.Contribute to the authoring and execution of implementation plans, qualification tests, and computerized system validation (CSV) documentation.Develop and maintain CSV standards, procedures, and work instructions to ensure consistent execution and regulatory compliance.Provide support for internal audits and regulatory inspections by ensuring system readiness, documentation accuracy, and timely response to findings or queries.Identify opportunities for innovation and process optimization based on evolving client and regulatory requirements.Qualifications and ExperienceB. Tech / M. Tech in Engineering, Computer Science, or related fieldMinimum 12 - 15 yrs work experience in relevant field.Veeva Vault Certification is preferred.Experience in Life Sciences / Pharmaceutical industry projects.Strong stakeholder management and communication skills.Skills Advanced Veeva Vault Configuration & Implementation in Veeva Vault Clinical – eTMF & QMS.Vault Deployment & Release Management, Package Migration & Validation Production Environment & global Veeva Vault Project Implementation.Awareness in risk-based validation approach (CSV - regulations) and inspection readiness expectations.Exposure to change governance, data integrity (ALCOA+) controls and business functionality.IT QA oversight responsibilities versus operational system administration.Depth in regulatory interpretation and inspection expectations , and practical application within computerized system oversight.Excellent written and verbal communication in English.Strong analytical and problem-solving skills with meticulous attention to detail.Effective collaboration and interpersonal skills for cross-functional teamwork.Adaptable, quick learner, with strong organizational and multitasking abilities.Working Condition:This position operates in an office seating in person.Job may additionally require incumbent to be available outside of these hours to handle priority business needs.Direct Report N/A