Description
My Client a global healthcare company are seeking a Quality Responsible person to join their teamPurpose
*Ensure the maintenance of the local Quality Management System (QMS) and its related documents, in alliance with the Quality principles outlined in the the companys global GCP /GVP Quality Manual.
organisation and/or the Medical Compliance Office (MCO).
*Identify QMS Affiliate Key Representatives (AKRs) within RPIL and work in partnership with the AKRs or other departments involved in GCP and GVP governed activities to maintain/enhance quality standards and to support and improve the efficiency of RPIL.
Key Tasks
Quality Management System
*Understand and implement the GCP/GVP QMS requirements for the business and monitor progress.
*Ensure that a GCP/GVP QMS Handbook (which references the company's globally GCP/GVP Quality Manual) is created and maintained for RPIL and followed by all relevant personnel.
*Ensure that an annual GCP/GVP Quality Plan is developed and monitored.
*Compile quarterly reports for global and RPIL Management Review, including collection, compilation, reporting, and analysing relevant data
*Ensure that all RPIL process documents that describe the QMS are properly maintained.
Performance Metrics
*Define metrics in collaboration with the business and PDQ:o Standardised metrics for monitoring the performance of the QMSo Additional RPIL indicators for monitoring the performance of key processes (KPIs).
*Measure and report QMS metrics and KPIs which give performance data on RPIL activities.
*Perform trend analysis on the KPIs for discussion at formal RPIL management reviews.
Communications
*Serve as a key contact for receiving QMS related updates and disseminate them appropriately through agreed communication channels.
QMS Records Compliance
*Ensure the records management requirements for QMS are established and followed by RPIL.
*Business Continuity
*Support RPIL Business Continuity activities from a GCP/GVP Quality perspective.
Vendor Management
*Ensure compliant vendor management processes are in place to ensure adequate oversight of vendors involved in GCP/GVP activities.
Clinical Trials
*Submit and maintain clinical trial applications to the Irish Medicines Board.
Person/Skills Profile
*University degree or equivalent in medical / pharmaceutical / scientific / healthcare discipline.
*Minimum of 3 years' experience in a quality/compliance role in the pharmaceutical industry.
*Project management skills.
*Ability to manage and analyse data.
If you are interested in this great opportunity and have the appropriate skills and experience please contact me Anna Mooney or apply below with an up to date CV.