QA Specialist

Brightwater

Waterford

A leading employer in the South East is looking to bolster it`s existing team by adding an experienced QA Specialist. Working specifically on a Tech Transfer project and reporting to the QA Team Lead you`ll work in a collaborative and dynamic environment. This is a 2 year contract with a competitive salary and benefits package. About the Job: Acts as Quality Point person for systems and processes by providing guidance and feedback on quality issues related to Sterile Manufacturing activities. 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. Ensure delivery to timelines consistently. Ensure compliance to cGMP at all times. About You: Minimum 5 year’s experience working in a Pharma/Biotech 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.

1896 days ago