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1007 Computer System Validation Consultant

Sunnyvale, CA
Computer System Validation Consultant
Sunnyvale, California
Contract
 
Position Summary Perform quality and compliance checks of activities during the project/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 coordinator for Change / CAPA / ER
  • Prepare and facilitate IT Change Review Board meetings
  • Initiate / monitor and track to closure of changes and CAPAs through tools like SolTraq, ServiceNow, etc
  • Understand SOPs, PCYC SLC
  • 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.

     
 
 
Regards,
Shagun Sachdeva
Senior Technical Recruiter
ReqRoute,Inc
Desk: 408-385-9607; Fax: 888-400-2698
email: shagun@reqroute.com
 
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Companies across U.S. have engaged ReqRoute, Inc to deliver skilled, dedicated IT professionals. Recruiting is our passion and we support Fortune 1000 companies with their hiring needs. We always seek to deliver competitive and sought-after career opportunities to our potential consultants and employees. We invite you to review the position requirements and apply today if your skills match our needs.  
 
ReqRoute, Inc is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. (www.reqroute.com)

 
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