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Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
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Details

Senior Associate Quality Operations


Reference:POR/185144 Location: Limerick
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Specialist

A Senior Associate Quality Operations is required to join a global biotech company based in Limerick. This role will be fully on site in a brand new start of the art manufacturing facility and will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products.


The role

  • Work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
  • Develop and maintain quality assurance procedures, policies, and systems
  • Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations
  • Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality
  • Maintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports

The Person

  • BSc Hons, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline
  • Minimum of 5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment
  • Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements
  • Experience with quality management systems (e.g., TrackWise, MES) is a plus

For further details please contact;Paula O’Reillyon 087 7094141 or send CV in confidence to [email protected]