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Quality Systems Specialist

Posted on almost 6 years ago by Laurentina Kennedy



QA Specialist – Quality Systems 

The QA Specialist – Quality Systems is part of the Quality Systems group within Technical Operations organisation based with our client Dublin. The QA Specialist – Quality Systems will support the application for an ongoing maintenance of all licenses at the Dublin site.


Maintaining, budgeting and updating the licenses
Coordinating contact with the relevant Health Authority (HA) with respect to licensing issues
Acting as SME and for Health Authorities during an inspection against the licenses
Support local licenses throughout the global affiliate network through technical support
Ensuring ongoing license compliance through Inspection Readiness projects
Act as GDP expert providing global support, as required, in current and future projects
To support, and where required take part in, GDP Audits to support local and global license compliance
To perform an assessment of current and upcoming regulatory guidance and legislation and to assess the impact to the company; those identified as impacting are to be communicated and/or integrated into systems as required
To assess the knowledge management process as applicable to the Quality Department.
From this, to develop a process to operationalise knowledge management within the Quality Department and to maintain this process on an ongoing basis; this will require metrics to demonstrate effective use of knowledge management within Quality
To generate and maintain Quality Technical Agreements for GDP and affiliate contractors
To participate in continuous improvement projects utilising Operational Excellence programs

Personal Competencies:
Bachelor's degree in. chemistry, biology or a related discipline
Experience working in finished product pharmaceutical/ biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
Experience with third-party vendor auditing, complaint handling and change control
Thorough understanding of quality systems and GMP/GDP

For further information on this QA Specialist Quality Systems position please contact Laurentina Kennedy at The RFT Group on 01 2302400 /
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