Quality Assurance Specialist

3 days ago


Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

As a key member of the Quality Assurance organization at Regeneron Ireland Dac, this role is responsible for ensuring that our IT systems and programs are robust and meet regulatory agency expectations.

The position will collaborate with the IT and broader QA teams to ensure all aspects of IT-related programs comply with regulatory agency expectations and internal company policies and procedures.

This includes:

  • Leading compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions
  • Investigating and troubleshooting problems which occur and determining solutions for changes and/or improvements
  • Reviewing, editing and approving deviation notifications, investigations, and corrective actions
  • Reviewing, editing and approving change control and SOPs
  • Participating and supporting the Quality Risk Management (QRM) principles in formal and informal risk assessment initiatives
  • Supporting the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process
  • Presenting and/or defending at both internal and external audits and presenting in a pressure test scenario the technical area that they are SME

This role might be suitable for someone who has detailed knowledge of 21CFR11 and Annex 11 as well as MHRA, FDA and WHO data integrity guidelines.

A solid understanding and experience with Computer Systems Validation and/or IT Auditing is also required.

To be considered for this position, you must hold a BA/BS degree and have relevant experience in a related field.

Senior Specialist requires a minimum of 5 years directly related experience within Pharma or Biotech or equivalent combination of education and experience.



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