Validation Lead

4 weeks ago


Oakland, United States Katalyst Healthcares and Life Sciences Full time
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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