Quality Management Specialist (Veeva Vault) vueverse.

8.0 - 12.0 years

0 Lacs

maharashtra

On-site

You are a highly experienced and motivated Subject Matter Expert (SME) for Veeva Vault QMS, responsible for leading the deployment and optimization of Quality Management System processes. Your deep domain expertise in QMS processes within the life sciences or pharmaceutical industry will be crucial in driving compliance, efficiency, and user adoption through effective system design and implementation. Your key responsibilities include serving as the SME for Veeva Vault QMS, leading deployment, configuration, and optimization efforts. You will analyze existing QMS processes and workflows, identify gaps, inefficiencies, and areas for improvement, and work closely with stakeholders, business users, and functional SMEs to gather requirements. Your role involves designing, implementing, and refining user-friendly QMS processes and workflows aligned with global regulatory requirements such as 21 CFR Part 11, GxP, and ISO standards. You will also support validation and testing of QMS functionalities, ensuring documentation compliance, provide training and ongoing support, and collaborate cross-functionally with various teams. To excel in this role, you should have a minimum of 8 years of experience in the QMS domain within pharma/biotech/life sciences, with proven expertise in leading or acting as an SME for Veeva Vault QMS deployment. Your deep understanding of Quality Management processes like CAPA, Change Control, Audit Management, and Deviations is essential, along with strong knowledge of industry regulations and compliance frameworks such as GxP, 21 CFR Part 11, and ISO standards. Excellent communication, stakeholder engagement, problem-solving skills, and experience in driving process design and change management initiatives are key requirements. Preferred qualifications include Veeva Vault QMS certification, a background in Quality Assurance or Regulatory Operations, and experience in global delivery models involving onsite-offshore collaboration. Your role as a liaison between business and technical teams will ensure seamless integration and solution delivery, making you a vital asset in the optimization of QMS processes.,

Posted 2 weeks ago

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