Cache of job #13652114

Job Title

Senior Gxp- Agile Computer Sys Val Lead

Employer

Independent Solutions

Location

Limerick

Description

Our client iscurrently seeking a Senior GxP- Agile Computer System Validation Lead to jointheir team.They develop, design and deliver high quality business applications, software solutions and services to meettheir business technology requirements. The offices are newly designed, specifically to accommodate Scrum development and are based on the University of Limerick Campus. It is an open and highly collaborative environment based on LEAN principles with a strong emphasis on continuous integration, automated testing and continuous delivery. Scrum teams are encouraged to be self-organising and autonomous. Responsibilities: Lead quality and compliance activities in relation to Agile software projects. 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 across multiple product portfolios, monitoring 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. Ensure Scrum teams are suitably resourced in relation to quality and compliance. Work with project teams to identify compliance issues following through to resolution. Disseminate written policies and procedures related to EDC compliance activities. Collaborate with teams to identify process improvements driving continuous improvement and efficiency and implementing change. Liaise with external regulators as required, facilitate internal and external audits, and manage corrective actions. Requirements: 8+ years of experience in GxP Software Compliance or other related discipline. Experience in a quality or compliance role within a Pharmaceutical / Medical Devices / GMP environment. Detailed understanding of SDLC and Agile development methodologies. Extensive Knowledge of the following FDA US Federal Food, Drug, and Cosmetic Act (FD&C Act. 21 CFR Part 11 21 CFR Part 11. 21 CFR 820 – Quality System Regulation. Association for the Advancement of Medical Instrumentation (AAMI. Sarbanes–Oxley Act(SOX. Health Insurance Portability and Accountability. HPRA (formerly IMB. European Union Directives (EudraLex) EU GMP Annex 11:Computerised Systems. The Medicines and Healthcare products Regulatory Agency (MHRA. Preferred qualifications: BSc. or Master`s degree in Computer Science or related technical field. Further Qualification in Quality or Compliance field is preferred. Excellent interpersonal and communication skills and an ability to work effectively with teams. Strong analytical skills and a demonstrable bias toward action. This job originally appeared on RecruitIreland.com.

Date Added

2626 days ago

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