QA Specialist - NPI - Waterford

Location: Ireland


Job Type: Perm

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1908-19277

Consultant: Karen McHugh

Are you a QA Specialist with experience in New Product Introductions in the Biotech / Pharma sectort?

Would you like to work for a multinational Biopharmaceutical company based in Waterford?

If you have the relevant experience, please forward your CV to for review or call 353 1 7978720 to discuss in confidence.

QA Specialist - NPI - Waterford


JobContax is a preferred supplier to one of the world's leading Healthcare companies. 

With major capital investment happening in their Waterford plant, this is an exciting time to join the team. 

Job Description

Reporting directly to the Quality Assurance Team Leader, you will play an integral role within New Product Introduction and Analytical Services, transforming the support provided to these functions.

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


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


Salary Negotiable depending on experience

Excellent benefits package

Flexible working hours

Further education opportunities


Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact him by e-mail or phone +353-1-7978720


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