QA Specialist

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My client is an established global pharmaceutical company based in South Dublin that are under a massive expansion. They are currently expanding their team and are looking for an experienced QA Specialist to join them on a 6 month contract.

Role: QA Specialist required for leading API site

Contract: 6 months opportunity to extend

Location: Dublin South

Rate: Hourly rate, depending on experience

What will you be doing?

The QA Specialist is responsible for the coordination of key quality activities within the Quality Systems and Compliance group and varying duties as assigned by the Quality Systems and Compliance Manager.

* Provide oversight and management of elements of the Quality Management System (QMS), which include, but not limited to, change control, deviations, CAPAS, Product Complaints, documentation, vendor management and risk management.

* Provide oversight and management of the supplier approval programme and the external audit schedule.

* Participate in the internal audit schedule.

* Administration/co-ordination of risk assessments.

* Develop and write SOP & Controlled Documents.

* Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.

What skills/experience should you have?

* Bachelor's degree in chemistry, biology or a related scientific discipline.

* A minimum of 10 years working within quality in the pharmaceutical industry.

* SME in ICH Q9 Risk Management, Supplier Management and or Product complaints is desirable.

* Thorough understanding of quality systems and cGMP's.

This is a great opportunity to join a truly global community. Not sure yet? No CV ready? Give me a call on 01-8883477 for more information!

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales