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  • DUBLIN 2
  • Job reference number:15430717
  • Client ID:RI/JO-1903-425771
  • Posted on:04-MAR-2019
  • Location:WATERFORD
  • Job type:PERMANENT

On behalf of our client, an expanding pharma company in the Waterford area, I am recruiting for an QA Officer for their Packaging division. This is an exciting new permanent role available.

Your role will be to support the Quality Assurance Manager with the development, implementation and maintenance of the quality standards and systems in relation to packaging operations to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs.

Key responsibilities:
To support the Quality Assurance Manager and Quality Assurance Team lead with the quality assurance function relating to packaging operations.
To ensure that all work carried out in is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
Implement and maintain the Vendor Qualification Programme.
Review and approve batch related documentation as required.
Generation and approval of SOPs.
Internal (self-inspections) and external QA auditor.
Liaise with packaging operations / laboratory personnel to ensure regulatory and quality requirements are met.
Assist with preparation of Submission Documentation in support of license applications and customer requirements.
Noncompliance reporting and corrective action / continuous improvement implementation.
Operation of SAP (ERP System) Quality function as per procedures

A third level degree incorporating Quality Assurance/ management
Ideally 3 years Quality Assurance experience in a pharmaceutical packaging environment.
Experience in packaging validation, Line clearance, Material reconciliation, packaging specifications, control of Artworks
Experience in Serialization implementation and execution.
Experience in managing customer and supplier complaints.
Lead auditor training complete
Internal audit experience
Experience with facilitating customer audits
Careful planning to achieve accurate and timely results to support the packaging plan.
Ability to define and manage own tasks and schedules

For futher details email your CV to or call +353 1 2784671

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