Job Description :
Role : Validation Tester with regulatory compliance exp Location : Foster City , CA Primary skillset: Validation, Deviation / CAPA management, Document control, change management Align activities as per expectation set for QRT Ensures the deliverables and tasks are adhered to the Client Process & CPI/KPI's Organize and moderate the deviation investigation meeting Moderate the root cause analysis meeting Prepare the interim documents on the required fields of Track wise or Deviation, CAPA, Change management, Emergency Change management Update the fields of the Track wise workflows from the approved content of interim documents Collaborate and follow up to complete the activities on time by the action owners of Deviation, CAPA, Change management, Emergency Change management Support/Perform Team lead on Periodic GxP reviews as per plan Plan, perform and report the Periodic GxP reviews Support the Sr. lead on exploring the opportunities for improvements in Client Process/Guidelines/Templates Support on improving the Client SOP's/templates Follow up with the stakeholders on the open action items on the action items arrived from the Deviations/CAPA/Periodic GxP Reviews/Document Control/Effectiveness Check Escalate well in advance in case of progress by action owner is not as expected Assist lead in preparing the Do's/Don'ts Share the data for metrics to the QRT lead Completing the trainings on time Thanks &

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