Senior Quality Assurance Manager

2 weeks ago

Shannon, Ireland beBeeQuality Full time €60,000 - €80,000

Job Summary

We are seeking an experienced Senior Quality Assurance Specialist to join our team. In this role, you will be responsible for providing quality assurance support and oversight to our Irish operations team.

About the Role

  • Provide quality assurance support and oversight to the Irish operations team ensuring compliance with EU, Irish and FDA cGxP regulatory requirements, QMS and any other applicable regulations/standards.
  • Review and approve quality documentation generated in Irish operations e.g., including but not limited to Deviations, CAPAs, change controls, logbooks, SOPs, risk assessments, OOO/OOT, temperature logs, etc.
  • Support a “Quality on the Shop Floor” culture through completion of facility walk rounds (including gowning into sterile facility) to maintain a high level of compliance and QA oversight by working closely together with operations ensuring proactive approach to identify potential issues and minimise impact.
  • Generate and prepare quality documents e.g., SOP's and controlled documents e.g., SOPs and Training Material.
  • Ensure compliant and adequate systems are in place to monitor investigations, CAPAs, audits and Quality Review Boards.
  • Support the preparation, execution and follow up on regulatory inspections.
  • Perform self-inspections in a timely manner as per plan.
  • Perform external audits of key suppliers and service providers where required.
  • Review QA for the eQMS system documents.
  • Gather data on status/performance of the Quality Management Systems to support Quality Council Meetings.
  • Aid in the management and proactively initiate and support continuous improvement of the Quality Management System.
  • Deliver GxP compliance training to operational areas.

What We Offer

We offer a competitive compensation package, opportunities for professional growth and development, and a dynamic work environment.

About Us

We are a leading organization in the field of [industry]. Our mission is to deliver high-quality products and services that meet the needs of our customers.

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