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
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