QA Specialist

Responsibilities:
QA Specialist is required to carry out most of his/her duties in the within the Quality integrated teams function and the primary tasks and responsibilities of the position are as follows.

Will report to the QA lead
Provide quality oversight and expertise as required for manufacturing operations.
Review of all manufacturing batch documentation including electronic batch records, Real Time reports, and master data.
Responsible for 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, 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 integrated technology department
Leading out of specification investigation
Working as directed by QA Lead according to Company safety policies, cGMP and cGLP

Key Requirements:
Bachelor's Degree or higher preferred; ideally in a related Science discipline
Experience in working within a manufacturing facility (IMB and FDA approved)
Expertise in Aseptic Assurance and Process Simulations, an advantage.
Experience in batch review, electronic batch record, an advantage.
Previous use of SAP/Trackwise, 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.