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Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
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Details

Senior Associate Quality for Computer Systems


Reference:POR/525612 Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Analyst, QA Executive

A Senior Associate Quality for Computer Systemsis required to join a global cutting-edge biotechnology company in Limerick. You will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within this next-generation manufacturing facility. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.

The Role

  • Develop and maintain quality assurance procedures, policies, and systems.
  • Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
  • Collaborate with automation, IT and production teams to ensure quality throughout the manufacturing process.
  • Investigate and address deviations, non-conformities, and CAPA to maintain quality.
  • Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for systems.
  • Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
The Person
  • BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
  • Minimum of 3 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.
  • Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus
For further details please contact;Paula O’Reillyon 087 7094141 or send CV in confidence to [email protected]