Regulated IT Application Developer

7 days ago


Dublin, Dublin City, Ireland Warman O'Brien Full time
About the Project

This project involves supporting a globally recognised Pharmaceutical company on behalf of an Engineering consultancy.

As a Senior Quality Software Engineer, your key responsibilities will include software quality assurance with review and approval experience for SDLC deliverables.

You will assess (FMEA) requirements, IQ, OQ, PQ, trace matrix, and system release.

In addition, you will support as SQA in the review and approval and implementation of regulated IT applications.

Furthermore, you will collaborate with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensure business needs are met.

About You
  • Strong validation capability with 8+ years' experience.
  • Previous experience with automated testing and implementation.
  • Proficient in understanding of GxP regulations and validation principles.
  • Good experience in review of CAPA's, change control, and defects as it applies to software validation.
  • Familiarity with a range of applications/tools/principles including JIRA, Confluence, Client-ALM, Tosca, Veera, Qtest, M-Files, ALCOA or other continuous integration tools.


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