Quality Assurance Officer

Lavipharm is seeking a Quality Assurance Officer, based in Athens who will be responsible for the implementation of the quality system, conducting quality assurance audits, monitoring and recording results from processes and procedures, as well as, taking corrective measures if any deviation is found.

Responsibilities

Compliance & Regulatory Oversight

•  Follows international standards and complies with regulations

Documentation & Record Management

•    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)