Senior Manager, Vault Quality Technical Analyst

Merck Sharp & Dohme (MSD)

4 - 7 years

6 - 9 Lacs

hyderabad

Posted:17 hours ago| Platform:

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Skills Required

quality process capa data analysis x-ray test cases auditing quality operations documentation tools process mapping quality systems operations quality management stakeholder management sop qms agile vault communication skills jira inspection

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

Required Skills and Qualifications:

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.

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