Leading Quality Assurance Professional

18 hours ago

Cork, Cork, Ireland beBeeQuality Full time
Senior Quality Assurance Specialist

Seeking a seasoned quality assurance professional to lead our team in upholding the highest standards of quality and regulatory adherence. This role requires a strong background in quality management, excellent communication skills, and the ability to drive continuous improvement initiatives.

Key Responsibilities:
  • Quality Review and Approval: Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation, ensuring full compliance with GMP and site-specific requirements.
  • Product Disposition Management: Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
  • Regulatory Monitoring: Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
  • Policy Development: Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
  • Continuous Improvement: Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
  • Risk Management: Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.
  • Internal Audits: Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.
Requirements:
  • Degree in Science, Quality, or a related Technical field.
  • 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
  • Hands-on experience with quality management systems such as Veeva, SAP, PAS-X, or similar platforms.

If interested in this opportunity, please contact Rachel Kent at Life Science Recruitment for further information.

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