Quality engineer (import of medical products) in Yuriya-Farm, TOV

YURI-PHARM is a Ukrainian pharmaceutical group of companies that owns the largest area of ​​production facilities in Ukraine. We already operate in more than 50 countries and have ambitious goals to enter the TOP 100 global pharmaceutical companies. Today, in the conditions of martial law, without stopping for a single day, we continue to provide both the civilian population and the Armed Forces with essential medicines and medical products. We invite a quality engineer to the team. We offer: official employment; competitive salary and annual bonus based on work results; safe and modern office, free meals; laptop, corporate mobile communication; annual vacation lasting 30 calendar days, instead of 24 according to the Labor Code; material assistance in various life situations; career growth and corporate development programs. Main tasks: Evaluation of technical documentation for imported medical products for compliance with regulatory requirements, ensuring interaction with foreign manufacturers. Evaluation of contract manufacturers, their qualification and approval. Development of Technical files and accompanying documents for imported medical products. Development of legal documents, such as as a Quality Agreement, Power of Attorney from the manufacturer to the Authorized Representative, etc. Submission of an application to the Conformity Assessment Body/Regulatory Service for the purpose of certification/registration of the MV, passing further supervisory audits. Tracking changes of the contract manufacturer, certification of these changes in Ukraine. Participation in the investigation of complaints regarding products. Construction of new and support of existing QMS processes, their documentation. Necessary knowledge and skills: Complete higher education (master’s degree/ specialist) in the field of pharmaceutical drug technology/ chemical technology/ biotechnology/ pharmacy/ quality, standardization and certificationKnowledge of basic ND regarding MV ( ISO 13485; Directive 93/42/EEC, Technical Regulation No. 753, EN ISO 14971, etc.) English Intermediate, skills in working with MS Office programs Experience in working with documents for more than 1 year (skills in developing documentation, translating documents into English) Communicability, responsibility