Compliance Specialist Quality Systems

Job Overview

Our client a large pharmaceutical based in the Tipperary area have a job available for an experienced Compliance Specialist, reporting directly to the Quality Systems Manager you will be responsible for the key duties below:

* Review any available relevant Quality System key performance indicators (KPI's) and provide accurate and timely data to the QS manager/QP.
* Management of the Corrective Action Preventative Action system, its continuous improvement and assessment of CAPA's for closure.
* Contribute to the continuous improvement of all quality systems on site ensuring that they are effective, meeting both regulatory requirements and company objectives.
* Support and assist the QS Manager/QP as required particularly in relation to regulatory audits e.g. FDA, HPRA.
* Review, update and approve QS Procedures as required.
* Review CFRs, European directives/guidelines; all internal/customer/regulatory audits, regulatory websites (for warning letters, 483s etc.) and highlight any relevant topics/items.
* Formulate any necessary regulatory/compliance action plans.
* Participate in internal and external audits.
* Carry out all functions in accordance with cGMPs and company policies/procedures.
The successful candidate should have;

* A 3rd level degree qualification, ideally in a Science discipline.
* Demonstrated experience in the Pharmaceutical/Healthcare regulated sectors.
* Proven experience of at least 5 years working closely in the design or operation of Quality Systems.
* Technical writing skills.
For more details or to apply contact Elizabeth on 056 7775550
"Tipperary, Tipp, Pharma, Job, jobs, regulatory, compliance, FDA, QS, Quality systems, QP, continuous improvement, Kilkenny, Waterford, Quality"

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