Quality Engineer

Description Overview

In this role you will act as the Quality lead for assigned production issues and strategic quality themes, providing oversight, continuity and challenge to strengthen operational quality processes, controls and governance. 

You will identify recurring risks and systemic issues, ensure learning is translated into sustainable improvements, and support effective management of quality risk within manufacturing operations.  

Scope of the Role

• Maintain oversight of assigned quality themes and recurring quality issues, identifying trends, emerging risks and systemic failure modes.
• Connect learning across deviations, complaints, audits and operational events to ensure sustainable risk reduction and continuous improvement.
• Provide Quality leadership and oversight during significant quality issues, investigations and escalations.
• Challenge investigation scope, root cause analysis and proposed actions to ensure quality risks are appropriately addressed.
• Support the development and implementation of robust, risk-based operational quality controls and processes.
• Monitor effectiveness of improvements and escalate where issues continue to recur or controls remain ineffective.
• Partner with Operations and other functions to ensure quality risks are identified, understood and effectively managed.
• Provide Quality input to change controls, validation activities and operational improvement initiatives where required.
• Support site quality governance through data analysis, trend monitoring and risk-based recommendations.
• Undertake such other reasonable duties as may be required from time to time in order to support the Perrigo business.

Experience Required

• Must hold a degree or equivalent qualification in a science, engineering or related discipline.
• Experience within a regulated manufacturing environment, preferably pharmaceutical or healthcare.
• Demonstrate knowledge of pharmaceutical legislation and a good understanding of GMPs, Quality Systems and Quality Risk Management Principles.
• Experience analysing quality data, trends and recurring issues to identify improvement opportunities.
• Strong investigation, problem-solving and root cause analysis skills.
• Effective technical writing and communication skills.
• Ability to influence cross-functional teams and provide constructive challenge.
• Proficient in Microsoft Office applications.