Hope you doing well,
we do have opening with one of our Client please go through the below Job 
Description and share profiles to vi...@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


*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*


-         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 

-         Expert knowledge of GAMP5, Quality Management, Computer Systems 
Validation (CSV) and change management in a GxP environment.


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