QA Specialist

Ireland  ‐ Onsite
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Description

Responsibilities:



* Provide quality oversight and expertise as required for manufacturing operations.



* Review of all manufacturing batch documentation including electronic batch records, real time reports, master data.



* Supporting deviation and atypical close out and initiating/following up on corrective and preventative actions using the site SAP system as a tool.



* Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines; as well as regulatory requirements.  



* Assist in the proactive evaluation of site compliance against emerging regulatory trends. 



* Drive continuous improvement by leading and active participation in system failure investigations and investigation reports, execution/development of change control.



* Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; oversee and implement subsequent corrective action through the change management system.



* Review and approval of validation documents, change controls, SOP's for the IPT department

Leading out of specification investigation



Experience:



* Bachelors Degree or higher preferred; ideally in a related Science discipline



* Experience of working within a manufacturing facility (IMB and FDA approved)



* Experience in Aseptic Assurance and Process Simulations, will be an advantage.



* Experience in batch review, electronic batch record, would be an advantage.



* Previous use of SAP/Trackwise, would be beneficial.



* A proven track record of effectively working with a manufacturing operations team to ensure best practices are implemented and improved.
Start date
n.a
From
Quanta Consultancy Services
Published at
15.07.2015
Contact person:
Lee Mitchell
Project ID:
944575
Contract type
Freelance
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