Sr Section Lead, Mkt Complaint

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Monitoring compliance to local and global requirements as defined in the procedures of Market Complaint, Field Action function.

• Ensure market complaint investigations and related activities are completed as per specified timelines in procedures.

• Collaborating with sub-functional and functional leaders across the company for market complaint related investigation.

• Support the Field Actions (Product/Mock Recall) & Corporate Product Hold & related activities.

• Review / Approve the Field Alert Report (FAR) or Quality Defect Report (QDR) assessment & communicate to external stakeholders/partners for regulatory notification (as applicable).

• Ensure that QMS elements such as Document Change Request (DCR), Change Control Management (CCM) or Non-conformity (NCR) and Corrective and Preventive Action (CAPA) related to function are processed and closed appropriately.

• Conducts market complaint trending including review of investigation reports.

• Monitor that all the function related KPIs & targets are met, as per requirement.

• Facilitates professional development, training, for functional Staff.

• Escalate the non-compliances (if any) observed with the resolution proposals for discussions with the Department of Head

•  To be the part of all internal and external audits and inspections and prepare the response of observations raised during regulatory inspections associated with Market Complaint and retain sample with Audit & Inspection team. Ensuring data is provided for data for Audit(s).

•  To monitor and plan day to day activities related to Retain Sample (RS) management on day-to-day basis and to communicate the challenges, updates, compliance levels to Head of Department.

• Responsible to drive the continuous improvement plans with Head Quality and cross functional partners, and to ensure all time readiness of the facility in response to the regulatory Inspections.

•  Ensure end to end process of retain sample management - ensuring the facility of storage in state operation for intended usage, qualification, and necessary modification.

• Review global procedure and update local procedure as and when required.

• Review manufacturing out of Specification (OOS) and Out of Trend (OOT) report and support in investigation.

• Ensuring trend preparation of Market complaint / LBINV elements as per the frequency.

• To allocate work to the team and ensure the co-ordination within team and across cross functional team

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