Senior Quality Assurance Specialist

4 days ago

Shannon, Ireland beBeeQuality Full time €60,000 - €90,000
Job Overview

This position plays a pivotal role in ensuring the quality and compliance of our manufacturing site.

The successful candidate will be responsible for providing quality assurance support and oversight to ensure that all regulatory requirements are met.

  • Providing quality assurance support and oversight to ensure compliance with EU, Irish, and FDA cGxP regulatory requirements, QMS, and other applicable regulations/standards.
  • Reviewing and approving quality documentation generated in operations, including deviations, CAPAs, change controls, logbooks, SOPs, risk assessments, OOO/OOT, temperature logs, etc.
  • Maintaining high levels of compliance and quality oversight through regular facility walk rounds.
  • Generating and preparing quality documents, such as SOPs and controlled documents.
  • Ensuring compliant systems are in place to monitor investigations, CAPAs, audits, and quality review boards.
  • Supporting preparation, execution, and follow-up on regulatory inspections.
  • Performing self-inspections in a timely manner.
  • Performing external audits of key suppliers and service providers where required.
  • Providing QA review for eQMS system documents.
  • Gathering data on status/performance of the quality management system to support quality council meetings.
  • Aiding in the management and proactively initiating continuous improvement of the quality management system.
  • Delivering GxP compliance training to operational areas.
  • Ensuring own work complies with GMP, data integrity, and good documentation practice and is undertaken in accordance with applicable quality documents.

Key Qualifications include:

  • Strong knowledge of quality management systems and regulatory requirements.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team environment.
  • Proven problem-solving skills.
  • Highly organized and able to prioritize tasks effectively.
  • Strong analytical and technical skills.

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