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    Veeva QMS Consultant - San Francisco, United States - Ascii Group, LLC

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    Description

    Veeva QMS Consultant | San Francisco, CA | 6 months | Onsite | C2C

    Essential Skills:

    IT Manufacturing Domain (Qualification implementation and Advisory in Veeva QMS)

    • Minimum 6 years of IT experience in pharma domain for implementing and managing Veeva QMS.
    • Must have experience on implementation, consulting for Veeva QMS in Life Sciences.
    • Deep knowledge of Veeva QMS, Veeva Vault configuration, developing them in live projects based on client requirement.
    • Previous experience in the biotechnology / Pharmaceutical / Life Science or related industry implementing and validating computer systems that manage regulated information
    • Working knowledge of IT infrastructure qualification processes and IT operating procedures
    • Thoroughly familiar with Quality GxP IT compliance requirements.
    • Awareness of ITIL and Support Project Methodology.
    • Solid grasp of Information security and standard methodologies
    • Working knowledge of Document and Object record migration from legacy application to Veeva Vault.
    • Good technical knowledge in core technologies and platforms such as Java, .Net, XML, HTML, PL/SQL API.
    • In-depth knowledge of quality management principles and industry regulations (e.g., FDA, ISO).
    • Qualified on Global Quality tracking systems for initiation handling and closure of investigation

    Responsibilities:

    • Provide consulting, author proposals, design, build, Configure and support Veeva QMS, Veeva Vault based applications to meet business process and application requirements.
    • Provide training and support to employees on Veeva QMS, as well as on QMS procedures and best practices, in general.
    • Knowledge on handling events QARs, CAPAs, Change controls, qualification document review and compliance
    • Stay updated on industry trends and regulatory changes to ensure continuous compliance.
    • Lead the development and execution of QMS processes, including document control, change management, and CAPA (Corrective and Preventive Actions).
    • Collaborate with cross-functional teams to assess and enhance quality processes throughout the product lifecycle.
    • Drive continuous improvement initiatives to optimize QMS efficiency and effectiveness.
    • Prepare and present reports on quality metrics and compliance status to management.
    • Support the on-going regulatory compliance of the IT components for defined services to ensure the proper integration and functionality of the Veeva QMS system.
    • Strong project management skills with a focus on delivering results within deadlines.
    • Review and approve regulatory system changes and documentation
    • Solves a range of straightforward problems through knowledge and technical experience in own discipline with a moderate level of guidance
    • Support periodic reviews of the entire system and compile related reports during operation phase

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