Environmental Monitoring Professional / Специалист по обеспечению асептических условий производства

Are you looking for the opportunity to make our patients’ lives better and leave your footprint in Novo Nordisk filling plant in Russia? Then you might be interested in taking up the position of Environmental Monitoring (EM) Professional in Finished Products Manufacturing International Kaluga site.

The manufacturing site is designed in line with the European and Russian GMP standards and environment safety and energy efficiency requirements and was ready for production start 2015. Site Kaluga is working closely together with the International Operations office in Moscow, Russia. Here in Kaluga site, we are establishing a modern insulin production and the processes in scope are formulation, filling, inspection, assembly and packaging.

Your new role

As EM Professional you will be mostly focused on deviations handling in terms of classified areas contamination, aseptic behavior aspects, and other EM processes. Also, you will be responsible for design and update of the documents relevant to the EM processes - procedures, risk assessments, rationales, instructions, protocols, reports etc. You will provide and implement coming process changes, support and consult personal in hygiene, gowning, cleaning and aseptic questions and implement production improvement activities - organizing and leading requirement analysis, data collection, documentation and other productivity improvements related meetings with cross-functional teams and stakeholders at all levels.

Your skills & qualifications

To make it a success you need to have a higher education: Pharmacist, Microbiologist, Engineer, Chemist or other relevant university degree. Production experience is preferrable.

Knowledge of environmental monitoring in Aseptic area is an advantage. Strong knowledge to prepare and implement Standard Operating Procedures. Knowledge of English (both written and oral skills, Intermediate level). On a personal level, you have excellent planning, negotiation and communication skills, which enable you to continuously set direction, keep an overview of the state of progress and priorities accordingly. Additionally, you have a strong personal drive enabling you to persistently pursue your goals and achieve results.

Your new department

In the position of EM Professional you will be part of EM production support team working with systems and tools which taking under control all aseptic production aspects. EM support team also focused on deviations handling in terms of classified areas contamination and aseptic behavior aspects. The department consists of operators and professionals, all organized into teams.

В роли Специалиста по обеспечению асептических условий производства вы будете сосредоточены на работе с отклонениями, связанными с контаминацией в классифицированных зонах, аспектами асептического поведения и другими процессами EM (environmental monitoring).

Также вы будете отвечать за разработку и обновление документов, относящихся к процессам EM — процедур, оценок рисков, обоснований, инструкций, протоколов, отчетов и т. д.

Вы будете обеспечивать и внедрять предстоящие изменения процессов, оказывать поддержку и консультировать персонал по вопросам гигиены, переодевания, очистки и асептики, а также реализовывать мероприятия по улучшению производственных процессов — организовывать и проводить анализ требований, сбор данных, подготовку документации и другие встречи, направленные на повышение эффективности, совместно с кросс‑функциональными командами и стейкхолдерами на всех уровнях.