Vishākhapatnam, India
8 hours ago
Group Manager - Manufacturing Compliance
Ensure compliance & on-time implementation of corrective actions/preventive actions derived from Regulatory Inspections and Third party or Corporate Assessments through completion. Perform Regulatory Observations Network Assessments (RONA) to identify gaps at site and implement CAPAs within agreed timelines. Co-ordinate with site Inspection Readiness and global Subject Matter Experts for Inspection Readiness activities. Maintain the Inspection Readiness tracker and its timely update as per current information. Preparation of the manufacturing IR Meeting slide deck to present in site meetings and leadership meetings Responsible for coordinating governance meetings and notify any delays on time to management. Provide data for preparation of metrics for Inspection Readiness and Regulatory Inspections actions status. Lead the upstream compliance team to manage day to day support for manufacturing that includes CCF, CAPA, QRM and training etc. Responsible to provide guidance and conduct QRM Monitor the CAPA Life Cycle to ensure on time closure of CAPA and drive the metrics. Track/ Trend CAPA metrics and provide feedback to management on periodic basis in relation to CAPA. Develop strategy for improved compliance against the metrics and maintain systems to measure performance against established targets.
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