QA Specialist - Sterile Operations - Waterford


Location: Ireland

Negotiable

Job Type: Perm

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1908-19276

Consultant: Karen McHugh






Are you a QA Specialist with experience experience in sterile operations in particular the management and manufacture and release of sterile product?

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

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


QA Specialist - Sterile Operations - Waterford


Employer

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, as a critical leader, you will play an integral role within the Sterile Operations area, transforming the support provided to these functions.

The Quality Assurance Specialist has a primary role in:

Acts as Quality Point person for systems / processes providing guidance / 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


Requirements

Essential

Previous experience in sterile operations in particular the management and manufacture and release of sterile product

Provide ability to provide quality expertise & support to the QA team and site.

Proven ability to support the delivery of tasks in a highly regulated manufacturing environment

Effective technical knowledge of sterile manufacturing processes

Not essential

Minimum 5 year’s 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


Package

Salary Negotiable depending on experience

Excellent benefits package

Flexible working hours

Further education opportunities


Contact

Karen McHugh is the consultant managing this position.

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

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