QUALITY ASSURANCE MANAGER

MEFAR İLAÇ SANAYİ A.Ş.

Qualifications 

* University Degree in Pharmacy, Chemical Engineering, Chemistry or Biology, 

* Minimum 8 years of experience in quality assurance with minimum 3 years managerial experience in pharmaceutical industry 

* Fluency in both written and spoken English 

* Must be analytical , creative minded and result oriented 

* Strong interpersonal, negotiation,coordination,communication and coaching skills

* Proficiency in MS Office programs 

Job description 

* Responsible to improve the quality assurance system according to updated regulations Pro-actively follow the new regulations and implement them in the company. 

* Implement all QA processes and procedures 

* Implement customer complaint system and root-cause problem solving that eliminated major customer complaints since implementation. 

* As the head of the deviation committee, responsible for the evaluation and solving of deviation problems systematically 

* Review and approve all validation and qualification processes. 

* Establish key process indicators (KPI’s) and implement preventive and corrective actions to eliminate the root causes of poor quality and delivery problems, responsible for the continuance of GMP conditions. 

* Perform preparation of the master files of the products. 

* Responsible for the implementation of Change Management System, plan, determine deadlines, approve the completed and appropriate change control requests. 

* Responsible for the approval of the batches for shipment to the local and export customers warehouses. 

* Responsible for the approval of certificate of analysis including microbiological tests.

* Hire, train and manage the Quality Assurance team including validation and product release branches.