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Senior Associate QA

Quality & Laboratory
Dublin
Therese Keohane
Temporary
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Job Reference: JO-2008-65358_1598597845

Summary:


Our Dublin based multunational client is looking for a Senior Associate QA to join their Plant Quality Team to assist with complaint investigations


Overview:

The Plant Quality Assurance (PQA) Snr Associate will typically report to a QA Manager and is a core member of the site Quality Assurance team. The PQA Snr Associate will sit in the PQA organisation responsible for packaging activities and their main responsibility will be complaint investigations.
The scope of the complaint investigations will extend to formulation, aseptic filling and inspection and as such the Snr Associate will gain exposure to all of these processes.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.


Key Responsibilities:

*Perform complaint investigation related to product manufactured including Formulation, Filling, Inspection and Packaging.
* Perform all activities in compliance with Amgen safety standards and SOPs
* Write, review and approve Standard Operating Procedures in accordance with Policies.
* Provide Quality support for triage and investigation of Deviations
* Review and approval of Deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
* Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
* Review and approve cGMP records (e.g., deviations, CAPA, protocols, reports & SOP) ensuring compliance with appropriate documentation
* Support continuous improvement and Operational Excellence initiatives
* Any other tasks/projects assigned as per manager's request.

Requirements

* University degree. Engineering or Science related discipline preferred.
* Relevant experience (2 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and proven abilities in decision making
* Strong organizational skills, including ability to follow assignments through to completion
* Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
* Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
* Operational Excellence experience



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Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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