Job Description :
Role: Compliance/Regulatory Lead

Location: Foster City CA

Contract



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 TrackWise, ServiceNow, etc
Support periodic reviews
Support Audits and remediation’s through CAPA management
Support IT Training management
Support IT Vendor Management
Understand SOPs and mentor IT team
Review and coordinate the draft protocols/test cases
Review System Life Cycle and Validation deliverables
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 8 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.
Thanks & Regards,

Ram Sharma
X 135

Client : Vlink