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QA Specialist

06/02/2019 (09:31)
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My key client is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. They target diseases that lack effective therapies and affect relatively small numbers of patients. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.

Role: QA Specialist

Contract: 22 Month contract

Location: Cork

Monthly Rate: DOE

Day to Day:

* Partner with cross functional GMP departments to ensure Drug Substance and Secondary Packed material is manufactured and release in accordance with GMP.

* Review and Approval of electronic and paper production/packaging batch records

* Daily presence and support on the manufacturing floor

* Release of Raw Materials for production

* Support the Technology Transfer of a new product into the site including raw material and supplier qualification.

* Review and approve new or updates to standard operating procedures (SOPs) and master batch records

* Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.

Skills / Requirements:

* Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.

* Minimum 3 years’ relevant experience in a cGMP regulated manufacturing environment (Biotech desirable), with exhibited knowledge and proficiency in Quality Assurance and Compliance.

* Experience and ability to work cross functionally

* Experience in supporting manufacturing operations and batch record review is highly desirable

* Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors.

For immediate consideration, please apply below 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 (url removed)

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
Start Date
Contract Length
22 Months  
Job Reference
Job ID
Less than 10

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