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Ishika Agarwal
Associate Consultant
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Group Manager - Manufacturing Compliance
- LocationVishākhapatnam, India
-
IndustryPharmaceutical Manufacturing
Job Description
- 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.
Benefits
- Performance bonus
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