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 )*
*Consultant - IT Quality Analyst (Onsite)*
Onsite – IT Compliance Lead
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
- 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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