Senior QA Validation Specialist - Cargo Fleet, Middlesbrough, United Kingdom - KD Pharma Group

Description

Quality Validation Specialist

The role of Quality Validation Specialist is to ensure product and system quality. Responsibilities include:

• Evaluate engineering systems based on safety and performance standards.
• Analyze results and update activity logs.
• Design validation protocols meeting safety and quality requirements.
• Conduct validation tests for processes, equipment, or products.
• Lead data analysis using software like Minitab to ensure quality performance stability.
• Manage Validation Master Plan and Calibration Master Plan.
• Perform product testing in the laboratory and record results.
• Review and revise specifications for products and processes.
• Support Quality Manager with ISO 13485 quality management system.
• Write Standard Operating Procedures and quality documentation.
• Provide technical skills profile to meet business needs.
• Lead problem-solving, yield improvements, failure analysis, and FMEA activities.

Other responsibilities include:

• Manage Supplier and Customer quality complaints.
• Support corrective and preventative action initiatives.
• Train on topics related to Quality and the quality system.
• Lead audit activities and implement necessary corrective measures.
• Support New Product Development processes in cooperation with Regulatory Affairs.
• Implement improvements to increase product quality.
• Ensure effective communication between departments regarding quality information.

Additional duties as necessary to support operations of the Quality and Regulatory Affairs Department.