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Product Quality Manager

  1. Brussels
Brussels
  1. Contract
Competitive
  1. Compliance / Quality Assurance
26-04-2024
33993

This vacancy has now expired

Product Quality Manager - Belgium - 12-Month Contract 

We have an exciting opportunity for an Product Quality Manager based in Belgium to work with our esteemed client whose portfolio is focused on first-in-class product candidates engineered in collaboration with their academic partners which have translated immunology breakthroughs into medicines.

Responsibilities:
  • In close collaboration with vendors, TechOps teams and other Product Quality managers: Review of qualification and validation reports
  • Review quality agreements with external parties
  • Manage and review of deviation investigations, related corrective and preventive actions and manage review of change controls
  • Review batch record documentation and support release of commercial product
  • Manage or review of product complaints
  • Review and assess Product Quality Review (PQR) reports from vendors
  • Support the compiling of submission dossiers and related queries from Health Authorities
  • Review of internal quality documents
  • Monitor and trend vendor performance and maintain key performance indicators for key operational QA activities and services associated with the commercial activities.
  • Support the activities related to Product Quality Complaint Management

Requirements:
  • 5+ years of experience in a Quality Assurance role, preferably within biopharmaceuticals, with the majority of that time spent in the GMP/GDP area
  • In-depth knowledge of FDA, PMDA, NMPA, EU regulations and ICH Guidelines
  • Experience in the Product Quality Complaint Management
  • Experience with manufacturing and/or lab activities is a plus
  • Ability to work independently and to make decisions based on experience.

If this role is of interest to you, please apply now! 

 #LI-CB1
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