Description
Our client, a global biotechnological organisation, is looking for a QA Specialist to support their Production activities onsite.Location: Ireland
Duration: 6-11 months
Start: January 2014
Description of Position:
The QA Specialist (IPT) shall 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 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
Working as directed by QA Lead-IPT according to Company safety policies, cGMP and cGLP
Qualifications, Skills & Experience required:
The successful applicant will possess the following knowledge, skills, qualifications and experience.
• Bachelor’s Degree or higher preferred; ideally in a related Science discipline
• Proven 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.