Hybrid Quality Assurance Officer

at Lavipharm

• Job title: Quality Assurance Officer
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Paiania, Greece

About the role

• 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
• Excellent Knowledge of the English language
• Computer Literacy (MS Office etc)