GxP Validation Lead

4 weeks ago


Alameda, United States I.T. Solutions, Inc. Full time

Role: GxP Validation Lead

Location: Onsite at Alameda, CA (2-3 Days)


The Validation Lead will be the primary liaison between product and quality teams to help validate number of products. The role will leverage strategic mindset to transform and adopt a risk-based approach to move the client towards Software Assurance.


In this role you will

  • Act as a Validation Lead for multiple products (applications) for GxP compliance
  • Assist 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
  • Analyze and propose changes to already validated systems and recommend requisite level of validation activities
  • Act as project manager for validation projects process
  • Responsible for overseeing other teams / individuals that are doing the actual executions (lead/coordinate/manage)
  • Act as single point of contact to plan, gauge workload, and help the multiple teams streamline to standards for multiple teams responsible for the validation of their individual products
  • 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

Skills and Qualifications

  • 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
  • Experience in managing other teams and individuals
  • Knowledge of GxP
  • Have good organization skills
  • Ability to work on multiple projects in parallel
  • Good verbal and written communication skills
  • Ability to provide guidance on revising validation documents and protocols


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