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QA Associate

Quality & Laboratory
Cork
Siobhán Lane
Temporary
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Job Reference: JO-2007-65285_1594278893

Summary:


RESPONSIBILITIES


* Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives


* Review and Approval of electronic and paper production 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.


* Support quality systems on site


* 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.


* Review and approve Change Control documents


* Assist with regulatory inspections.


* Support the following activities, as appropriate: Document Control, New or updates to relevant quality agreements, Process and Cleaning Validation activities, Continuous Improvement/Lean initiatives


* Compile and present metrics


* Other duties as assigned



REQUIREMENTS


* Minimum 4 years' relevant experience in a cGMP regulated manufacturing environment (Biotech desirable), with exhibited knowledge and proficiency in Quality Assurance and Compliance.


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


*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.


* Ability to comprehend technical information related to equipment, processes, and regulatory expectations.


* Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.




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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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