Senior Quality Assurance Specialist

Há 1 mês


Rio de Janeiro, Rio de Janeiro, Brasil Thermo Fisher Scientific Tempo inteiro
Job Summary

We are seeking a highly experienced Quality Assurance Specialist to join our team. As a key member of our Quality Management team, you will be responsible for providing R&D Quality support to Affiliate Medical teams.

Key Responsibilities

  • Review, monitor, and approve controlled process documents for quality, compliance, and commitment gaps.
  • Lead investigation and assist in Root Cause Analysis of Quality Issues (QI) and CAPA.
  • Review and approve Quality Issues (QI) and assist the CAPA owner in performing Root Cause Investigations.
  • Monitor CAPA to completion and ensure R&D Quality Management System maintenance in the Affiliate Medical Teams.
  • Support Affiliate Functional Learning Liaison in the maintenance of R&D QMS matrix and ensure Affiliate Medical Teams have available nominated Affiliate PON representative and CAPA Functional Approver.

Requirements

  • Degree in Life Sciences or Engineering.
  • Minimum 2 years of experience in CAPA management and Quality Audit/Inspection support activities.
  • Fluent in English and experience in TrackWise or other electronic Quality Management Systems (eQMS).
  • Strong understanding of procedural documents, process improvement fundamentals, and clinical management technology and systems.
  • Effective judgment, decision making, escalation, and risk management skills.

What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Quality Assurance Specialist looking for a new challenge, please apply today.


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