IT Quality Analyst (Onsite) - Sunnyvale, CA
From: <benchs3155_at_gmail.com>
Date: Thu, 12 Apr 2018 10:13:24 -0700 (PDT)
Message-ID: <7ddd90f9-eb5a-4a31-a159-554a90d0866d_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 )
Date: Thu, 12 Apr 2018 10:13:24 -0700 (PDT)
Message-ID: <7ddd90f9-eb5a-4a31-a159-554a90d0866d_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.