Description
Quality Assurance Engineer: QA, CSV, SDLC, Pharmaceutical, GxP
My client, a world renowned global organisation is seeking a Software Quality Engineer to join their Development Centre based in Limerick.
The responsibilities are as follows:
*Lead quality and compliance activities in relation to Agile software projects.
*Ensure Scrum teams are suitably resourced in relation to compliance.
*Liaise with Scrum teams and enterprise-wide quality and compliance colleagues to ensure projects follow GxP and other regulatory requirements.
*Support, guide, and educate Scrum teams, and monitor projects, to ensure that approved software development standards, processes, and procedures are adhered to, as well as make recommendations on the adoption of industry best-practices.
*Collaborate with teams to identify process improvements driving continuous improvement and efficiency and implementing change.
*Participate in leadership team meetings providing input into the direction of the IDC, provide relevant updates, and participate in relevant workshops.
*Assist with the implementation and rollout of the J&J AS Quality Management System. Write, review, and approve quality documentation including SOPs and WIs.
*Facilitate internal and external audits and manage corrective actions.
*Assist with internal and external communication, improving transparency, eliminating impediments, and providing metrics.
Requirements:
*5+ years of experience in Software Quality Assurance or other related discipline.
*Experience working within a regulated environment within the pharmaceutical or life sciences industries.
*Detailed understanding of the Software Development Lifecycle (SDLC) and an understanding of Agile development methodologies.