Senior Quality Assurance Specialist

3 weeks ago

Cork, Cork, Ireland RT Full time

Senior QA Specialist Co Tipperary

11 month FTC - may extend

Call Rachel today for more details

Key Responsibilities
  • 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.
  • Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
  • Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
  • Assist in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
  • Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
  • Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.
  • Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.
Education
  • 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.
  • Strong written and verbal communication skills, capable of clearly articulating complex quality issues.
  • Logical thinker with the ability to remain proactive and composed under pressure.
  • Proven ability to work effectively both independently and collaboratively within a team.
  • Exceptional attention to detail and precision in preparing and reviewing GMP documentation
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