Quality Assurance Specialist

Vem İlaç San. ve Tic. A.Ş.

• Graduated from the Chemical Engineering, Biomedical Engineering, Physics or Chemistry departments of universities,
• Preferably having at least 3 years of experience in Quality Assurance, Quality Management and GMP in the pharmaceutical company or medical sector
• Preferably knowledge about ISO 13485 and Medical Device Regulation
• Good command of English
• Good knowledge of GMP
• Good MS Office knowledge
• Ability to manage multitasking,
• Open to communication and social,
• Having strong communication skills, high personal motivation, prone to teamwork,

JOB DESCRIBTION

• Preparation of annual training plans,
  
• Tracking training reports and the compliance of the training plans,
• To contribute to the realization of the training programs of other departments,
• To keep track of individual training records,
• Contributing to increasing the knowledge level of cGMP related personnel in the field of work,
• Educate all employees (especially new employees), and visitors, of entering cleanrooms and working rules and monitoring their implementation.
• Working in coordination with the department manager and supervisor on establishing, applying and maintaining the quality management system and workplace environmental conditions,

• Analyzing the outputs of the quality management system (QMS) and GMP operations to monitor the success of target indicators,
• Documents and records QMS and GMP activities 

• Preparing technical file, product risk analysis, clinical evaluation reports of products and keeping them up-to-date
• Management of after-market surveillance activities, ensuring the implementation of the vigilance procedure
• Making necessary preparations for MDR studies
• Preparing the design file for new product design and existing product changes,
• Participation in ISO 13485 and medical device inspections, following the deviations and CAPA s related to inspections.