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.