Lavipharm

QA Engineer

• Follows international standards and complies with regulations
• Issues the annual "Product Quality Review" of all products
• Follows up the monthly stability studies of the QC Department and issues the relevant stability protocols and reports
• Ensures standard operating procedures and manufacturing documentation for all products is kept up to date
• Issues Process and Cleaning Validation Protocols, in accordance with the applicable Guidelines
• Evaluates the Plant and Laboratories for compliance with GMPs standards
• Reviews production batch documentation
• Issues, revises and reviews Standard Operating Procedures (SOPs) for the QMS system
• Issues, follows up and archives investigation of quality complaints with customers and suppliers
• Implements statistical evaluation studies for product release, shelf life and yield specifications
• Issues, follows up and archives investigation of quality deviations with the collaboration of the impacted department
• Issues, prepares, archives and follows up the change management system
• Issues, follows up and archives corrective and preventive actions
• Implements a thorough training program for all employees in the site

Quality Assurance Officer