Обязанности и достижения:
• Experience in manufacturing, science management and regulation in biotechnology and pharmaceuticals, successful management of several projects, full independence and efficiency in making decisions,
• experience in developing technology and biotech manufacturing in accordance with the requirements of GMP, supervising ongoing manufacturing, operational management, development of new technologies, procurement of modern technologies and equipment, purchasing of equipment, installation of new equipments, validation, quality management system, auditing, risk analysis, working with suppliers and subcontractors; marketing of production (design, labeling, packaging, etc.), business planning, knowledge of regulatory guidelines, recruitment, participation in settling disputes, knowledge of GMP, GCP, GLP, ISO standards, Clean Rm Stnds, regulatory requirements, aseptic technology,
• biotech industry expertise, regulatory process, assessing manufacturers’ technical files and design dossiers, auditing manufacturers’ quality systems, auditing aspects of the manufacturer’s design production, review design data (risk analysis, performance evaluation, stability and post market surveillance information and etc.), inspections, CE-marking,
• pharma industry expertise, project management, registration, interacting with different departments of the manufacturer, setting tasks, identifying of priority directions, the conclusion to new products on the market, B-to-B, interacting with regulatory authorities, budgeting, planning, correction of registration plans, interacting with foreign partners for decision of the joint problems, decision of the problem-solving questions with state regulatory organs, registration experience, registration dossiers, certification, internal and external audits, post-market monitoring and etc.