Начальник відділу аудиту постачальників фармацевтичного підприємства

Biopharma is a Ukrainian biotech company specializing in the production of medicines from donated human blood plasma. For more than 125 years we have been developing innovative medicines which save the lives of millions of people and return them to health. 

In our business we adhere to GMP standards and are exacting in our standards which regards to the quality of our products. The long-lasting confidence of our patients inspires us to new developments and achievements for a better life for society, because we care!

Head of Supplier Quality Assurance department 

Supplier Quality Engineer Requirements :

· Master's degree in a related field;

· Level of English –  В2 (Upper-Intermediate);

· Minimum of 2 years of experience in a similar role or in Quality Assurance Department or Supplier Quality Assurance;

· Advanced knowledge of government compliance and quality control regulatory standards;

· Ability to write audit reports;

· Ability to write Risk Assessment;

· Ability to present data effectively;

· Planning and prioritising activities skills;

· Excellent verbal and written communication skills;

· Experience of dealing with customers and suppliers;

· Strong computer skills;

· Strong problem-solving, organizational skills;

· Ability to work well in a team environment;

· Excellent analytical skills. 

 Supplier Quality Engineer Responsibilities:

· Creation of the annual schedule of audits of producers of raw materials, auxiliary substances and materials, distributors, computerized systems, transport services, outsourcing companies; 

· Organization of manufacturer/supplier risk assessment, оrganization of their survey;

· Lead the supplier approval process by assessing manufacturing/technology capabilities and Health, Safety risks;

· Organization of risk assessment of substances/materials;

· Evaluation and selection of outsourcing companies for conducting audits;

· Regularly visit suppliers and assist the supply chain group in conducting supplier audits;

· Prepare, update and coordinate incoming inspection plans;

· Provide concise, complete and accurate documentation of inspection results relative to area of responsibility;

· Create, issue and complete Supplier Corrective Action requests;

· Communicate and instruct suppliers on the use of corrective action process and quality tools and techniques;

· Facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers;

· Regularly communicate with Engineering, Manufacturing Engineering, and Supply Chain team members internally to identify opportunities for quality and productivity improvement;

· Development of SOPs;

· Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system;

· Contribute to continuous improvement activities;

· Produce written reports and make presentations;

· Undertake personal continuous training and development;

· Independently determine approach and assigned tasks.