GODESHI SINDHU

• Subject matter expert for processing market complaints, incidents, impact assessments, investigations to identify the root cause, and tracking of CAPAs.
• Drive execution of the global complaints business process, and maintain oversight of complaints throughout the lifecycle, from logging, processing, and effective closure.
• Management of adverse events and escalations by coordinating with respective business partners.
• Trending notifications, such as market complaints, incidents, and CAPAs.
• Communicate potential product quality or business risks to leadership, and escalate critical issues to senior management.
• Handling of change controls.
• Preparation, reviewing of quality assurance agreements.
• Execution of self-inspections and internal audits as a lead auditor.
• Handling of risk assessments.
• Create various KQIs/metrics for respective GxP activities for presentation in relevant forums.
• Preparation, review, and approval of SOPs, handling of SOP revisions, and life cycle management.
• Authoring and reviewing of annual product quality reports (APQRs).
• Implementation of continuous improvement initiatives to increase operational efficiency.
• Implementation of QMS requirements by identifying gaps and deficiencies in the established quality management system that can independently trigger, investigate, and implement the necessary corrective action in line with current external and internal standards to ensure the continuous evolution of the quality system.
• Continuously monitor the progress of data quality KPIs, and ensure adherence.
• Proactive identification and implementation of data quality checks for quality processes.
• Ensuring a good data quality score to maintain data that is accurate, complete, and consistent.
• Assist the Data Steward in defining business rules for the data and documenting metadata for various data elements.
• Work closely with the Data Stewards, Business SMEs, and DQ Managers to ensure the execution of data stewardship tasks as per the aligned stewardship agreement and standards.
• Liaise with the Functional Data Owners, Business SMEs, and Data Maintainers to discuss and resolve Data Governance and Quality issues.
• Review and approve data exceptions for the data created by the Data Maintenance team.
• Collaborate effectively with the data community to facilitate shared learning between Business Users and Stewards and to promote active Data Governance through the Data Governance team.
• Adherence to the Global Data Governance Framework.
• Management of metadata, data lineage, and data quality KPIs.
• Compliance and improvement in current data governance responsibilities.
• Accountability and ownership of assigned data objects.

· Handling of Incidents, impact assessments, investigations, market complaints to identify the root cause and handling, tracking of CAPAs.

· Trending of Notifications like Incidents, Market complaints and CAPA

· Handling of change controls.

· Preparation, reviewing of Quality assurance agreements.

· Participation in Self inspection and internal audits as a qualified auditor.

· Handling of Risk assessments.

· Create various KQI’s/metrics for respective GxP activities for presenting in relevant forums.

· Preparation, review and approval of SOPs, handling of SOP revisions.

· Authoring and Reviewing of APQRs

· Implementation of continuous improvement initiatives to increase operational efficiency

· Implementation of QMS requirements by identifying gaps/ deficiencies in the established quality management system that can independently trigger, investigate and implement the necessary corrective action in line with current external and internal standards to ensure continuous evolution of the quality system.

· Participating in Regulatory audits like MHRA, FDA, ANVISA and customer audits.

· Preparation, review and approval of Elemental impurity risk assessments of drug products.

· Stability Protocol preparation, Stability batches tracking and maintenance of stability chambers.