Job Description
The Product Quality Complaints Specialist is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for pipe-line products and in-line products, whilst supporting management and the team on tasks, projects, and daily operations.
The Product Quality Complaints Specialist Complaints works across Technical Operations and other functions to execute Product Quality Surveillance strategies. Specifically, Product Quality Complaint investigation and approval, and supporting APQR, Product Recall, Incident Management, and Integration of new product acquisitions as appropriate.
Responsibilities
Process global commercial / clinical product Quality Complaints:
Assess incoming Product Quality Complaints (PQC) elevating potential issues/ incidents to management, including but not limited to PDRs, MDRs or possible recall situations
Critical evaluation of Customer Report complaints for serious cGMP and Device/ Combination product violations.
Performs Management review and final closure in TrackWise of Patient Inquires, Partner Notifications and Customer Report Complaints.
Point of contact for International colleagues.Provides guidance to global partners and ensures compliance to global procedures.
Coordinate process and review PQC investigations performed at contract site manufacturer / packagers and site investigations in conjunction with Quality Assurance. Leads investigation meetings as required.
Assign actions related to each Product Quality Complaint investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actions
Perform trend analysis on all incoming PQCs escalating to incidents as required
Communicate adverse events reported in conjunction with PQCs to PVRM
Facilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection / investigation
Generate final correspondence summarising investigational findings to complainant / or communicate via the relevant international QA contact to ensure local communication requirements are met.
Develops and implements actions associated with product quality complaints and trends.
Compiles and communicates product quality complaint performance measures
Backup to management in support of regulatory notification or market correction activities (e.g. PQDR, field alert / recall activities)
Support and facilitate integration of products entering the in-line supply chain into Quality Systems
Contact for generating reports for management and inspections as required
SME for the preparation of data for internal audits and external audits / inspections in the international market
Maintain awareness of MHRA/EMA/FDA/DEA, etc. regulatory actions that may affect products.
Education & Qualification
Bachelors degree in a relevant scientific/engineering discipline with GMP industry experience, the majority of which has been gained in the QA environment
Scientifically strong with technical expertise to ensure robust analysis of complex product data, and the ability to assess information to make scientifically sound quality risk based recommendations.
Working knowledge of GMP / GDP Regulations, including US and EU Regulations.
For further information on this Product Quality Complaints Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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