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Quality Compliance Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBee Careers Full time

This position requires a strong focus on quality systems, including ISO 13485, 21 CFR Part 820, and EU GMP. As a Quality Specialist, Compliance, you will be responsible for maintaining compliance with regulatory requirements, providing training and analytical support, and ensuring effective implementation of quality management systems.

Main Responsibilities:
  • Sub-administer the site Quality Event Management System to manage Quality Records.
  • Oversee Quality document control and provide guidance on documentation structures and format.
  • Support software updates and validation for the MasterControl System.
  • Develop and implement training programs for Systems and Document Management.
  • Generate data for Management Review and Site Metrics reporting.
  • Manage off-site Records Management Suppliers and Processes.
  • Ensure compliance with GMP review requirements.
  • Coordinate cross-functional teams for successful documentation releases.
  • Promote quality awareness and participation in Quality Projects.
  • Participate in internal audits and third-party assessments.
Qualifications:
  • Relevant third-level qualification and 3 years of experience in a regulated industry.