Product Quality Manager
il y a 4 semaines
Product Quality Manager - Belgium - 12-Month Contract
**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.
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