Hi,   
   Hope you doing well,   
   we do have opening with one of our Client please go through the below Job   
   Description and share profiles to vijay@santeksystem.com / 510-256-5798   
   (please don't share profile if you not able to provide passport num )   
      
   Job Title   
   	   
      
   Consultant - IT Quality Analyst (Onsite)   
      
   Reporting To   
   	   
      
   Onsite – IT Compliance Lead   
      
   Location   
   	   
      
   Sunnyvale, CA     
      
   	   
      
   Position Summary   
   	   
      
   Perform quality and compliance checks of activities during the p   
   oject/operational phase of the computerized system. Train the support teams on   
   defined SOPs, track open issues and risks and ensure they are addressed by   
   respective teams.   
      
   Key Result Areas   
   	   
      
   -         Play the role of change coordinator   
      
   -         Prepare and facilitate IT Change Review Board meetings   
      
   -         Initiate / monitor and track to closure of changes and CAPAs through   
   tools like SolTraq, SNow, etc   
      
   -         Understand SOPs, client System Life Cycle   
      
   -         Understand existing processes in application area   
      
   -         Review and coordinate the draft protocols/test cases   
      
   -         Review validation deliverables   
      
   -         Support periodic reviews   
      
   -         Manage and monitor Audit and CAPA management   
      
   -         Align and report to IT Compliance Lead   
      
   -         Co-ordinate with offshore team to share the tasks and meet   
   deliverable timelines   
      
   Qualification   
   	   
      
   -         Minimum requirement is a Bachelor’s Degree in Computer Science,   
   Sciences or a related education (e.g. life science, medicine, commercial).   
      
   -         Minimum 4 years Professional experience in managing quality /   
   compliance in the regulated environments in a Pharmaceutical/Life Sciences   
   Organization.   
      
   -         Expert knowledge of GAMP5, Quality Management, Computer Systems   
   Validation (CSV) and change management in a GxP environment.   
      
       
      
   --- SoupGate-Win32 v1.05   
    * Origin: you cannot sedate... all the things you hate (1:229/2)