Quality Assurance Officer overseeing quality system implementation at Lavipharm in Athens. Responsible for compliance, audits, and quality improvement in the manufacturing process.
Responsibilities
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
Requirements
Bachelor degree in Chemistry, Biochemistry, Analytical Chemistry or other relevant field
At least 3 years experience in Quality manufacturing/systems preferably in Human Pharma Industry
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