Good Morning! I have a new requirement for a Validation Lead position located 
in Vernon Hills, IL. It is a 6 month contract with the possibility of 
extension. Below is the job description.

     

    Location: Vernon Hills, IL

     

     

   
     

  Validation Lead 
   
  Purpose:  This consultant will act as a Validation lead within the Quality 
Organization.  The project encompasses 4 distinct applications configured four 
our client’s use as well as multiple interfaces to integrate the applications 
to each other and existing systems.
   
  Critical Job Responsibilities
    
   Generate Validation Master Plans, Qualification Protocols, Test Plans, Risk 
Assessments, Reports, Trace Matrix, as needed   
   Participate in and guide team in generating user requirements, functional 
and design specifications   
   Gain understanding and follow defined SDLC.  Ensure quality validation 
processes are executed as defined by procedures   
   With team, develop validation strategy for system.  Deploy strategy, 
defining documentation requirements and hierarchy for multi-application system. 
  
   Communicate status, solutions and concerns,  Disseminate information in a 
timely manner within the team.  Facilitate and address issues within project.   
 
   Manage validation team—coordinate documentation and testing  Generate test 
scripts, as needed.  Execute testing as required.   
   Collaborate with business, quality and technical individuals throughout 
project in generation of project/validation required deliverables   
   Prepare validation package for archival 
     

    
    Must Haves: FDA Regulated Experience, be able to start immediately, 
excellent communication. Over three years as a Lead in an FDA Regulated 
environment. 
    Please send me any qualified candidates you have asap. I need to send 
candidates by close of business today.

     



Dave, 
Technical Recruiter 
COOLSOFT LLC, 
Phone: 502-442-7707 EXT 116 
[EMAIL PROTECTED] 
www.coolsofttech.com 
Yahoo IM: dave_coolsoft 

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