QA Specialist

Description

Role - QA Specialist
Location - Carlow, Ireland
Type - Initially 11 month contract
Start - January 2014
Working pattern - Operation 24/7 so flexibility for shift work required
Rate - Hourly rate TBC + 33.3% rate uplift if required to work on shifts

Responsibilities:
QA Specialist is required to carry out most of his/her duties in the within the Quality IPT function and the primary tasks and responsibilities of the position are as follows.
Will report to the QA lead-IPT
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.
Responsible for supporting deviation and a typical 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, and contribution to Kaizen events as appropriate.
Manage root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues eg 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
Working as directed by QA Lead-IPT according to Company safety policies, cGMP and cGLP

Key Requirements:
Bachelors Degree or higher preferred; ideally in a related Science discipline
At least 3 years experience working within a manufacturing facility (IMB and FDA approved)
Expertise 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.
Ability to critically review analytical data. Possessing excellent attention to detail is a must.
Ability to trouble shoot, identify microbiological issues and follow up with corrective actions.
Experience of preparing for and participating in regulatory audits in particular IMB/FDA.