quality control manager.

The main resposibilities for the Quality Control Manager position will be the following:

• Responsible for Setting up Pharmaceutical QC Lab Site, carryout all equipment and area qualifications and start commercial supplies.
• Oversees/ participates the Computer System Validation activities related to the instrumental equipment.
• Contributes to the design of the Data Integrity (DI) principles throughout the QMS, by training the QC personnel on its implementation.
• The role is responsible for issuing the SOPs/Wis that are required for the proper operation of the QC lab.
• Oversees, directs and participates to the analytical method transfer activities and method validations that will take place according to the timelines that will be set.
• Analyzes, evaluates and investigates OOS (Out of Specification) & OOT cases (Out Of Trend) approving the respective LIRs.
• Evaluates proposals for chemistry supplies orders and submits for approval to the Head of Quality Management for the purpose monitoring the budget.
• All personnel who work in QC department and directly or indirectly support cGMP activities, have the necessary education knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
• Manages headcount and participates in setting the site annual budget and quarterly forecasting processes.
• Leads the QC team to excellent performance through a structured manufacturing system based upon SMS with the use of Operational Excellence tools.
• Creates functional excellence for area of responsibility and helps to integrate that capability into daily operational practices.
• Follows and complies to all good practices (GMP, GDP), to the Quality Management System, regulatory requirements, internal processes and procedures, company guidelines, the corporate governance code, the Health Safety and Environment (EHS) procedures and good practices and all company policies and regulations, and actively contributes to their improvement.
• Ensures and protects data integrity in every action.
• Undertakes any other project or responsibility that is assigned by the company, within the broader scope of the position’s responsibilities.

• 3-4 years of progressive technical/operational leadership experience or equivalent.
• At least 5 years of pharmaceutical cGMP experience

• Bachelors or master’s degree in Chemistry, Biology, Pharmacy, Chemical Engineering or any relevant field.
• Excellent oral and written communication
• Fluent in Greek & English
• Customer focused and dedicated to meeting the expectations and requirements of internal and external customers.
• Time Management efficiency, uses time effectively and efficiently; concentrates efforts on the more important priorities.
• Dealing with Ambiguity, can effectively cope with change; doesn't have to finish things before moving on.