Senior Quality Assurance Specialist

1 day ago

Cork, Cork, Ireland beBeeQuality Full time €54,000 - €72,000
Quality Assurance Specialist Position

This is an exciting opportunity to join our organization as a Quality Assurance Specialist. The ideal candidate will be responsible for leading change controls, managing product disposition, and monitoring regulatory guidance.

Key Responsibilities:
  • Change Control Lead: Ensure full compliance with Good Manufacturing Practice (GMP) regulations by reviewing and approving change controls, deviations, and CAPAs.
  • Product Disposition Manager: Make timely and compliant decisions regarding product disposition, ensuring that all quality systems are met.
  • Regulatory Guidance Monitor: Stay up-to-date on new regulatory guidelines and industry best practices, assessing their impact on quality systems and driving updates as necessary.
Required Qualifications & Experience:
  • 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.
  • Hands-on experience with quality management systems such as Veeva, SAP, PAS-X or similar platforms.
Why You'll Thrive Here:
  • Opportunity to make a real difference in the quality of our products.
  • Collaborative and dynamic work environment.
  • Professional growth and development opportunities.

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