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Job description

**ROLE OVERVIEW/ PURPOSE:** - Management of the EU and UK Product Quality Complaint (PQC) process - Responsible for monitoring of incoming complaints and preparing the required Initiation and close out forms - Responsible to generate EU KPIs for these systems. - Also to support other QMS systems in the processing and/or monitoring as required **Responsibilities:** - The management of the Product Quality Complaint (PQC) System for EU and UK marketed products as well as for EU affiliates where no QMS representatives are present, and ensuring compliance with European GMP requirements and local regulations. - Act as the point of contact for PQCs in the UK and EU and manage the EU Complaints mailbox. - Process PQCs from initiation to closure as per procedure. - Monthly co-ordination of all PQC KPIs with each EU affiliate - Execute consolidation of all PQC KPIs on a monthly basis including preparation of the dashboard for senior management review - Preparation of monthly KPIs regarding the PQC system at European level (consolidation of data provided by sites/affiliates) - To update trackers and maintain complaint investigation documentation in compliance with cGMP requirements. - Ensuring timely assessment and preliminary response to critical complaints, including sample evaluation where applicable. - Conduct meetings with GCS, PV, LPVRP, QA and other stakeholders to ensure reconciliation and end-to-end closure of Product Quality Complaints (PQC). - Trending of PQCs and escalation to Senior Management based on repetitions and critically. - Act as back up and support for other QMS systems in the processing and/or monitoring as required - Effective communication between stakeholders e.g PV, RA, NPI, EU QMS, RP, QP (local, EU and Global)