Quality specialist

компания "rb" primary activities would generally include but not be limited to release products to the russian market. responsibilities: to check the compliance of each imported batch with regard to the approved normative document (nd)/ru pharmacopeia based on the certificate of analysis (coa) issued by the manufacturer of the medicinal product; to check, confirm and document the compliance of each imported batch with the requirements of the relevant product marketing authorization in russian federation; to provide rozdravnadzor with all information in accordance with the requirements in the federal drug law as the precondition to be fulfilled prior the distribution of the batch in the territory of the russian federation; to clarify with the qualified person (qp) of the manufactures questions raising up during the check of the coas prohibiting the distribution of the product in russia; to organize the cooperation with other departments/manufacture to get the regular input mandatory for the business. e.g. access to approved nds; ru-gmp status of manufactures, cooperation with qps from manufacturer; responsible for archiving all relevant documentation according to company rules; elaborates internal procedures in the framework of a quality management system which ensures that compliance of processes with legal obligation and internal rules; propose actions to improve the quality management system and lead the implementation. qualification: strong interpersonal skills and great attention to detail are necessary; must be able to influence decisions based on regulatory knowledge, and must have excellent problem solving, as well as verbal and written communication skills; must have adequate computer experience (knowledge of microsoft word, excel and powerpoint); must have knowledge of russian regulations, application of good manufacturing and distribution practices; must demonstrate excellent critical thinking skills and understanding of complex manufacturing processes and make risk based quality decisions on deviations based on knowledge of regulations and regulatory trends. exrerience&education: more than 2 years of related work experience is required; chemical, pharmaceutical, biotech related is preferred; english (upper-intermediate).