Manager, Vault Quality Support Engineer

Merck Sharp & Dohme (MSD)

2 - 7 years

4 - 9 Lacs

hyderabad

Posted:8 hours ago| Platform:

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Skills Required

quality process capa data analysis document management system x-ray configuration edms quality operations veeva system administration technical support quality management qms management systems user management agile vault communication skills jira

Work Mode

Work from Office

Job Type

Full Time

Job Description

Provide operational and technical support for the Veeva Vault Quality platform.
Collaborate with Quality, Compliance, and IT teams to ensure smooth functioning of Veeva Vault applications.
Assist in maintaining and enhancing the Vault environment to meet business and regulatory requirements.
Key Responsibilities

Key Responsibilities

Support day-to-day operations of Veeva Vault Quality modules (e.g., QualityDocs, QMS, Audit, Issues, Inspections, Complaints, Change Control).
Troubleshoot and resolve user issues related to Vault Quality applications.
Manage user access, roles, and permissions within Veeva Vault.
Assist in configuration and administration of Vault workflows, lifecycles, and metadata.
Coordinate with Veeva Vault administrators and external vendors for system upgrades, patches, and validations.
Generate reports and dashboards to support Quality Operations metrics and KPIs.
Participate in system validation activities, including test case creation, execution, and documentation.
Provide support materials to end-users to improve adoption and compliance.
Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GxP) in system operations.
Document processes, SOPs, and support tickets related to Vault Quality Operations.

Required Skills and Qualifications

Experience with Veeva Vault Quality (Quality Docs & QMS).
Strong understanding of Quality processes such as Deviations, CAPA, Change Control, Document Management, Complaints and Audits.
Veeva Certifications (Veeva Vault/Vault Quality Suite/ QMS). The role holder has completed the Certified Vault Training and is up to date.
2+ years in technical support, tooling/platform support, or system administration.
Knowledge of regulatory requirements relevant to pharmaceutical/biotech industries.
Proficiency in system administration, configuration, and user management within Veeva Vault.
Ability to troubleshoot technical issues and coordinate with IT and vendors.
Strong communication skills to liaise between technical teams and business users.
Experience with system validation and quality documentation.
Experience using JIRA/XRAY for test case management, test execution, reporting, defect management within Agile environments.
Familiarity with reporting tools and data analysis.
Detail-oriented with strong organizational skills.

Preferred Qualifications

Experience working in a regulated environment (pharma, biotech, medical devices).
Knowledge of electronic document management systems (EDMS).
Experience with scripting or automation tools related to Vault operations.

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