Description
A leading global pharmaceutical organisation requires a Quality Engineering Head to join their team based in their manufacturing facility in Italy. You will provide Quality Engineering oversight of all operations performed within Operations group. You will be expected to be an effective and respected leader of the Bulk QA leadership team.The Role:
*To ensure that critical investigations are appropriately managed in line with site quality standards and in accordance with regulatory and global requirements.
*Complete thorough RCA and effective CAPA planning to eliminate operational and personnel management issues.
*Drive continuous improvement to enable best in class performance across Quality, Customer Service, Financial and HSE performance goals.
*To provide leadership to the Quality Engineering team and to ensure that they are fully trained, developed and motivated to achieve their full potential.
*To establish quality objectives and KPI`s for the operations; and to ensure these objectives are met and continuous improvement is demonstrated. Monthly tracking and reporting
*To promote a culture of Operational Excellence (OE) including Lean and Six Sigma through the application of IQP programmes.
*Provide Root Cause Analysis (RCA) and Quality on the Shop Floor (QASF) support for all critical deviations within Operations. Identify areas of recurring DRs, and breakdown of root causes within each segment (e.g., personnel, equipment, etc.).
*Support improvements to Quality Systems (process mapping of APR mgmt, Change Control mgmt, etc.).
*To ensure that Quality Operations are managed in a cost effective manner in line with the approved budget and efficiency improvement targets.
Experience:
*Italian (or conversational/fluent in Italian) / Conversational English
*Degree in Chemical or Biotechnology Engineering or an Advanced Science w/at least 10 - 20 years Quality and Operations experience in either Bulk Vaccines or Bulk Biopharmaceutical Manufacturing
*Blackbelt or Greenbelt in Operational Excellence - Thorough understanding and application of Lean & Six Sigma principles
*Substantial industry experience in a site producing biological pharmaceutical products under EU and US standards, including both quality and operations management experience
*A proactive approach which builds Quality & Compliance into processes
*A track record in cementing teams and delivering outstanding effectiveness from those teams
*Good track record with the FDA, MHRA, EMEA and other regulatory agencies
*It is expected that this position will lead to senior position within the team
This is an exceptional opportunity to manage and work alongside a fantastic Quality Engineering team.Set in a superb Italian based location this is a career opportunity not to be missed.
Please apply today highlighting your key skills and relevant experience aligned to this opportunity.