Job Description
JO-2410-542369
Our client - a leading global medical technology company, requires an experienced Laboratory Lead for their new R&D facility in South Dublin. The successful candidate will support the start-up and implementation of the Quality laboratory and the qualification of lab equipment, processes, and/or test methods related to product release and complaints testing
Role
- As the Quality Laboratory Leader - you will set priorities for the Quality Lab and be accountable for the success of all deliverables, while ensuring related operations
- Will support start-up and implementation of the Quality laboratory and the qualification of lab equipment, processes, and/or test methods related to product release and complaints testing. Activities include, but are not limited to, identification of product defects and potential issues, data analysis, and trending.
- Responsible for final batch release and complaints processes for commercial product, including the management of any associated outsourced activities.
- Supports the continuous improvement of testing and/or quality assurance process, provides technical support on equipment and methods, and is responsible for proactively managing complex issues with a high level of autonomy.
- Supervises technicians performing complaints and/or release activities.
- Conducts on-boarding and ongoing training program of lab associates.
- Maintains good laboratory practices (GLP) consistent with corporate and regulatory guidelines.
- Maintains good documentation practices (GDP) when generating test data and records in accordance with ISO, cGMP and other applicable regulations and standards.
Complaints Management:
- Manages and drives completion of commercial product complaints activities: planning, sample management, investigations, reporting, oversight of activities performed by support team(s) and/or supplier(s)
- Performs complaint Quality Data Analysis, as needed. Identifies and reports trends and/or triggers for significant complaint issues
- Product Release:
- Performs final product release operations. Maintains documentation, reviews inspection results, and dispositions product.
- Initiates or performs non-conformance investigations, if needed.
- Trends incoming inspection data, as needed.
- Identifies and reports trends and/or triggers for initiating supplier complaints.
Requirements
• Bachelor degree in Engineering, Science, or other related discipline.
• Min 5 years relevant experience: Pharmaceutical, medical device, diagnostics, or Quality Control.
• Knowledge of the operation of mechanical measurement and testing equipment (e.g. Instron) and CT scanners
• Understanding of industry standards and regulations such as ISO, FDA, OSHA, ASTM
• General knowledge of problem-solving and root cause analysis methodology
• General knowledge of statistical techniques
Desirable:
• Education or experience related to electromechanics and/or electromechanical devices highly desirable.
• Ability to troubleshoot electromechanical devices and software highly desirable
• Experience with equipment qualification desirable
• Experience with computer system validation desirable