· Responsible for planning LS process/ regulatory audits and monitoring the effectiveness of process implementation at project level · Responsible for auditing Work Products (including Study and cases) and deliverables to ensure that defined processes are adhered to meet customer quality requirements · Responsible for facilitating implementation of Process improvements · Provide feedback for continuous improvement of Quality Management System · Responsible for identifying tailored processes at an account / project level and reporting them to the QC / QM · Responsible for best practice identification and evangelizing adoption at project level · Responsible for reporting on status and effectiveness of process implementation at project level · Responsible for verification of CA / PA and closure of NC / Observation. · Responsible for SOP review · Responsible for driving Inspection readiness initiative · Responsible for facing Client and regulatory audits/ inspection · Responsible for facilitation, reviewing CAPA for external findings. · Responsible for driving Organizational initiatives |
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