QP Quality Director

CPL

Tipperary

A start up Pharmaceutical Site in Tipperary have an immediate requirement for a QP Quality Director to join their team. As Quality Director, you will be a key member of the Site Leadership Team maintaining a robust Quality Management System, allowing us to build the highest quality pharmaceutical products in a progressive and fast paced environment. Job Responsibilities : Determine and establish department structure and reporting relationships within the function in collaboration with senior management. Ensure that appropriate SOP’s for various GMP functions as necessary are prepared, reviewed, training imparted and approved. Generate and monitor appropriate trends/KPIs for Quality System processes and implement a Continuous Improvement programme for the Quality System. Working with Global Quality Management, develop, review, and endorse Quality Standards for the assurance of Good Manufacturing Practice consistent with regulatory requirements and Company objectives. Act as Primary Qualified Person (QP), (we have QP resources on site. Prior to QP release, ensure all commercial batches comply with the requirements of the Marketing Authorisation and have been manufactured according to the principles of cGMP as per 21 CFR 210/211 and Directive 2003/94/EC. Prior to QP release, ensure all investigational medicinal product batches comply with the requirements of the Clinical Trial Authorisation as applicable, the Product Specification file and have been manufactured according to the principles of cGMP as per 21 CFR 210/211 and Directive 2003/94/EC. If interested in having a confidential discussion then please contact Eoin Coffey on 061 221707 or email eoin.coffey@cpl.ie. This job originally appeared on RecruitIreland.com.

2445 days ago