Quality Assurance Specialist

2 weeks ago


Limerick, Limerick, Ireland beBeeQuality Full time €98,765 - €123,456
Job Title: Quality Assurance Specialist

We are seeking a skilled and detail-oriented Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of product quality and compliance in our electronic systems.

  • Develop, maintain and implement quality assurance procedures, policies and systems.
  • Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
  • Investigate and address deviations, non-conformities and Corrective and Preventive Actions (CAPA) to maintain quality.
  • Review and approve change controls related to GxP systems and lab equipment, ensuring appropriate impact and risk assessments.
  • Apply ICH Q9 principles to qualify and mitigate risks in system-related changes or deviations.
Key Responsibilities:
  • Quality Assurance Design and Oversight
  • Regulatory Compliance
  • Documentation and Reporting
  • Quality Improvement Initiatives
  • Training and Development
Requirements:
  • Bachelor's degree in Science, Engineering, Quality or related field.
  • Minimum 5 years of experience in quality assurance within a biotechnology, pharmaceutical or medical device manufacturing environment.
  • Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
  • Excellent problem-solving and analytical skills.
  • Detail-oriented with a strong commitment to maintaining high-quality standards.
What We Offer:

Competitive salary and benefits package, opportunities for professional growth and development, and a dynamic work environment.



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