Reporting to the QA Manager, the Quality Engineer is responsible for managing the technical quality aspects for their respective areas working closely with the operations team to deliver on achieving all key department metrics.
• Responsible for all operational quality aspects associated with product manufacture and release.
• Responsible for the successful validation and qualification of process and raw material changes.
• Investigate Quality problems associated with the production department and implement effective corrective and preventive measures.
• Support introduction of new products into the site ensure products are designed and validated to the required quality and regulatory standards.
• Ensures key quality metrics (CAPA management, First Pass Quality, Complaints, ect) are attained.
• Drive/support & implement continuous improvement projects with the operations team using Process Excellence lean/six sigma tools.
• Ensures the pertinent corporate quality and regulatory standards are attained.
• Maintains strong communication with internal and external stakeholders.
• Participates and supports the Internal and External Audit Programme.
• Apply G.M.P and observe that is it being adhered to in the department.
• Participate in teams to help make necessary improvements and changes to all process related issues in the production department.
• Identify and Implement continuous improvements in conjunction with the operations team.
• Liaise with Vendors and Customers on quality related issues, internal and external.
• Supervises team of Quality Techs\ inspectors as required.
• Additional duties as required.
You have a university degree (Level 8) in a Science or Engineering related discipline
- 2 + years or relevant within pharma or biopharma