Quality Assurance Specialist

7 days ago


Dublin, Dublin City, Ireland The RFT Group Full time

The RFT Group is seeking a highly skilled Quality Control Team Leader to serve as the point of contact for commercial product complaints and post-market product vigilant monitoring processes.

Responsibilities
  • Coordinate all aspects of investigation through to closure and/or provide oversight for complaint handling process.
  • Apply departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
  • Assess product complaints and determine if escalation is required due to potential regulatory notification requirements.
  • Interface and collaborate with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc. and the regional organisation.
  • Ensure that all product complaints are investigated to the appropriate level within the required timeline.
  • Send customer response letters where required.

This role requires a strong attention to detail, good organizational skills and well-structured approach to work, prioritizing tasks based on risk or criticality - seeking effective solutions within the complexity that surrounds product complaints.



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