IT Quality Analyst (Onsite) - Sunnyvale, CA

From: <benchs3155_at_gmail.com>
Date: Thu, 12 Apr 2018 10:13:46 -0700 (PDT)
Message-ID: <f5231cf5-09db-491e-af22-d20e3608d45c_at_googlegroups.com>

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_at_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 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 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.

Received on Thu Apr 12 2018 - 19:13:46 CEST