Senior QA Specialist

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Would you like to work in a QA team who is creative, passionate, collaborative and determined to succeed?

My key client offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.

The Senior QA Specialist is responsible for implementing and monitoring the operation of the Quality Management systems in place under the company's Wholesale Distribution Authorization according to current legislative requirements including EU Good Distribution Practice, Irish legislation, and guidance from the HPRA to ensure that the provisions of the Authorization are observed.

The Senior QA Specialist should have a working knowledge of the legislative basis pertaining to wholesaling of medicinal products at both European and local Irish level.

Role: Senior QA Specialist

Contract: 6 month hourly rate contract

Location: Dublin

Duties and Responsibilities

Quality Management

* Ensure that a quality management system proportionate to the distributor's activities is implemented and maintained including: self-inspection; quality risk management; corrective and preventative actions (CAPA) to address deviations; recall; change control; vendor management;

* Participate/lead in internal and external compliance audits.

Personnel

* Carry out all duties in such a way as to ensure that the wholesale distributor can demonstrate GDP compliance.

Premises

* Ensure that appropriate standards of GDP are maintained for own premises and contracted storage premises.

Documentation

* Accuracy and quality of records

* Contemporaneous records

Operations

* Carry out bona fide checks to ensure that suppliers and customers are qualified.

* Manage authorized activities to ensure operations do not compromise the quality of medicines and can demonstrate compliance with GDP.

Education and Experience

* Minimum of a Bachelor's Degree in Science or a healthcare related field and a minimum of 4-6 year's relevant experience of medicinal products is required

* Excellent knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) Wholesale Distribution Authorisation (WDA).

* Working knowledge of logistics and serialization would be desirable.

This is an excellent opportunity for an experienced Senior Quality Assurance Specialist who is looking for a role in Dublin.

For immediate consideration please apply with an up to date CV. Not sure yet? No CV ready? Give me a call 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