Quality Assurance Manager overseeing pharmaceutical quality systems and compliance. Ensuring manufacturing and documentation meet GMP standards.
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)
Job title
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