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  • DUBLIN 2
  • Job reference number:15450316
  • Client ID:RI/AM16760
  • Posted on:10-JUN-2019
  • Location:WATERFORD
  • Job type:PERMANENT

Quality Assurance Officer - County Waterford.

In this role you will 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 cGMP's.

Key Responsibilities:

To support the Quality Assurance Manager and Quality Assurance Team lead with the quality assurance function relating to packaging operations.
Check own work and that of others for accuracy before / prior to ‘QA Authorisation’ of documentation.
QA Reviewer of Process Compliance Change Controls
Implement and maintain the Vendor Qualification Programme.
Review and approve batch related documentation as required.
Generation and approval of SOP's.
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.
Non-compliance reporting and corrective action / continuous improvement implementation.
Support the on-going OOS/OOT/ Deviation/CAPA closeout programme.
Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
To assist in the preparation for customer/ regulatory inspections.
Attend cross-functional team meetings as a Quality Assurance representative

Interested applicants should have:

A third level degree incorporating Quality Assurance/ management
At least 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 completed
Internal audit experience
Experience with facilitating customer audits

This job originally appeared on RecruitIreland.com