Quality Specialist - Npi

Brightwater

Waterford

One of the South East`s most prestigious employers is seeking an experienced Quality Assurance Specialist to join it`s high performing team. This is a full time role on a 23 month contract with an attractive salary and full benefits package. About the Job: Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues related to New Product Introduction. Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP. Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk. Work with relevant departments to ensure timely closure of quality actions / findings. Actively contribute to continuous improvement initiatives. About You. Previous experience in NPI in particular the management and manufacture and release of IMPs. Provide ability to provide quality expertise & support to the QA team and site. Proven ability to support the delivery of projects across multiple platforms. Effective technical knowledge of sterile manufacturing processes. 5 years’ experience working in a Sterile manufacturing environment. Effective technical knowledge of sterile manufacturing processes. Operational experience of quality systems in a dynamic manufacturing environment. Knowledge of requirements for cGMP, US and EU regulatory requirements. Full understanding of relevant quality and compliance regulations. Able to manage projects to plan/budget. Effective facilitator. Good communication skills at organisation, team and individual levels. Understands KPI’s for the team and site. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

1838 days ago