Product Quality Specialist

5 days ago


Dublin, Dublin City, Ireland Cpl Healthcare Full time

We are currently collaborating with B. Braun, a leading healthcare supplier and top medical devices company, to recruit a Product Quality & Complaints Coordinator.

Job Description

This is a hybrid role, with 2 days in the office and the remainder remote, reporting to the Regulatory Affairs Manager.

  • Support the effective management and coordination of regulatory activities relating to products on the Irish market.
  • Manage product complaints from initial receipt through to closure, in conjunction with the Global Complaints Departments.
  • Liaise with customers regarding product quality issues and medical/technical/clinical queries.
Key Responsibilities
  1. Review product complaint investigation reports and document correspondence / letters for customers.
  2. Assist in the coordination, implementation, and documentation of product recalls, field safety corrective actions, quality defect investigations, compliance issues, vigilance issues, and mock recalls.
  3. Provide periodic training to relevant personnel on product quality complaints, medicovigilance, and pharmacovigilance.
Requirements

A 3rd level qualification in a life science or pharmacy related discipline, ideally with 3 years' work experience in a Medical Device/Pharmaceutical Industry and a good understanding of GDP.



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