Validation Engineer, Sunnyvale, California
Prashant G
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. Monitor Training compliance of IT staff. |
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 SolTraq, ServiceNow, etc · Understand SOPs, PCYC SLC · 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. |