Quality assurance manager

1. Function Description
Job Title - Quality Assurance Manager
Department -Quality Assurance Department
Supervisor - Executive Manager
Subordinate Employees -All employees from Farmaco Quality Assurance Department
Area of application -Farmaco, MD-Moldova
Basis - Organisation chart Farmaco SA

2. Goals
• Leading of Quality Assurance Department
• implementation of Quality Management System
• Implementation and effects of the policies of the parent company
• Qualified Person for the local & national Authorities
• Pharmacovigilance elaboration rules and cooperation
• Batch Release of Production

3. Tasks / Responsibilities
• Definition of objectives and ensure the achievement of goals
• Quality Management Organization, control and deposit of documentation’s
• Responsibility to be obtain the Marketing Authorization’s
• Coordination with Health Authorities
• Ensuring relevant compliance and Pharma guidelines
• Maintenance of the Marketing Authorization’s
• Organization and coordination of existing Quality Management System
• Preparation of local needed documents parts for Quality Management
• Elaboration of different SOP’s in Quality Assurance Department
• Quality Assurance of release batch production

4. Management Tasks
• Management Assisting of Executive Manager
• Report files to the Executive Manager
• Management and promotion of the employees placed below

5. Competencies
• According to the guidelines of the Company’s policies
• According with the delegated competencies of Farmaco Administrator’s

6. Subject Requirement’s
• Pharmacist / Doctor
• Minimum 5 Years of experience in the pharma sector
• Minimum 3 Years of management experience
• Knowledge of c'GMP regulators
• Experience with supervisory authority ( FDA / EMA / Moldova Rules )
• Experience with Pharmacovigilance
• Communicative and team oriented
• Romanian, Russian and English ( or German or French ) spoken and written
• Resilience, flexibility, initiative