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    Validation Lead - Oakland, United States - Katalyst Healthcares and Life Sciences

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    Description
    Responsibilities :
    • ct as a Validation Lead for multiple products (applications) for GxP compliance
    • ssist building a standardized method of enabling / implementing the SOPs for the GxP applications and getting the teams to adopt the standard approach
    • Manage and execute validation plans and validation documents for new systems in scope
    • nalyze and propose changes to already validated systems and recommend requisite level of validation activities
    • ct as project manager for validation projects process
    • Coordinate with business to support the required software change
    • Help create system requirements and specifications to ensure requirements can be tested to meet the validation goals
    • Support auditing of internal computer systems validation activities, protocol and procedures along with preparing appropriate responses
    • Initiate / Prepare and closeout all validation related deviations, discrepancies and change control documents
    • Support development teams in creating, and maintaining test plans, test scripts and user acceptance tests
    • Manage the execution of test plans
    • Guide the teams in the proper execution of validation documents
    Requirements:
    • Overall 15+ years IT experience
    • 8+ years of relevant experience in computer system Validation preferably in a pharma company
    • Experience and good knowledge in CSV / CSA
    • Knowledge of GxP
    • Have good organization skills
    • bility to work on multiple projects in parallel
    • Good verbal and written communication skills
    • bility to provide guidance on revising validation documents and protocols

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