Quality System Compliance Manager

5 days ago


Dublin, Dublin City, Ireland TN Ireland Full time

About the Job Description

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  • This job description outlines the key responsibilities and expectations for the Quality System Compliance Manager position at TN Ireland.

In this role, you will be responsible for maintaining the ongoing compliance of the Quality Management System and providing guidance on documentation structures and format to ensure compliance with procedures, relevant regulations, and standards.

Key Responsibilities

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  • Maintaining the ongoing compliance of the Quality Management System.
  • Providing guidance on documentation structures and format to ensure compliance with procedures, relevant regulations, and standards.
  • Sub Administrator for the site Quality Event Management System to manage and maintain traceable, accountable Quality Records in compliance with Corporate Guidelines.
  • Quality document control oversight on documentation and reports.
  • Support Global Systems Administrator in software updates and validation relating to the MasterControl System.
  • Management of Systems Training – developing, scheduling, and performing.
  • Management of Document Management Training on site – developing, scheduling, and performing.
  • Management of GMP Training including Induction and Annual – developing and performing.
  • Generation of data for Management Review.
  • Site Metrics generation (weekly and monthly) including reporting out Globally.
  • Off-site Records Management Supplier.
  • Process Confirmation program on site.
  • GMP review requirements to maintain compliance with customer requirements and enterprise procedures.
  • Cross-functional work with individuals and project teams to ensure successful documentation release.
  • Compliance representative on Quality Projects within the site.
  • Internal Audit Program.
  • Preparation and hosting of Third-Party Audits including audit training and control room set up.
  • QMS compliance tracking and trending of issues and patterns to drive improvements.
  • Interface with other West sites regarding sharing of best practices.
  • Company's Guiding Principles and adherence to the corporate Code of Conduct.
  • Site Environmental, Health and Safety requirements, training, and regulations.
  • Local site company policies, procedures, and corporate policies.
  • Other duties as assigned.


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