Computer Systems Validation Expert

1 day ago


Limerick, Limerick, Ireland TN Ireland Full time

We're looking for a skilled Computer Systems Validation Expert to join our quality assurance team at TN Ireland. As a key member of our team, you will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.

Job Description:

  1. Computer Systems Quality:
    Play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility.
  2. Regulatory Compliance:
    Stay up-to-date with industry regulations, guidelines, and best practices.

Qualifications:

  • BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
  • 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.


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