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1007 Computer System Validation Consultant

Sunnyvale, CA
Computer System Validation Consultant
Sunnyvale, California
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
  • 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.

Shagun Sachdeva
Senior Technical Recruiter
Desk: 408-385-9607; Fax: 888-400-2698
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