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Вакансия

Quality Assurance / Pharmacovigilance Specialist
Москва, Ново Нордиск
Размещено: 07.11.2017

You will join a team of highly skilled professionals responsible for business in CIS countries (Azerbaijan, Georgia, Armenia, Uzbekistan, Turkmenistan, Tajikistan, Kyrgyzstan and Mongolia). You will report to the GM CIS Rising Markets (CIS RM) and be located at Moscow office facility in Krylatskie Hills Business Park.

ОБЯЗАННОСТИ

The position

In your new role you will ensure QMS (Quality Management System) in affiliates in compliance with Novo Nordisk A/S and with current legislation locally as well as internationally.

You will develop, approve and upload local procedures in QBIQ; you will be responsible for handling reviews and comments on procedure drafts and responsible for e-signature workflows in Novodocs for document approvals; you will be ISOtrain Training Coordinator; approve SOP deviations for clinical trials.

Also, you will be responsible for OmniRIM Local record Manager system (archiving); handle Change controls and Non Conformities; follow up in implementation of Quality activity plans within the unit; prepare Quality Management Review input and minutes of meeting with identified action points.

Audit and Training

You will participate in Corporate Quality audits; conduct Quality audits of GxP partners; you will be responsible for overview of local quality laws and requirements in countries; Product Release Responsible for Novo Nordisk products in affiliates; you will conduct Induction training of new employees on Novo Nordisk Quality Management System.

Repackaging

You will co-ordinate and prepare repackaging plan for the products with distributors; review and approve the Batch documentation of Repackaging. Develop and sign Quality agreements with partners.

Pharmacovigilance

You will establish and maintain a Pharmacovigilance system in the affiliate according to local requirements and the international requirements. Also, you will be responsible in Maintenance of/and Customer complaints, Adverse events and Severe adverse events.

Направление деятельности Другое
Занятость Полная
Минимальное образование Высшее (Фармацевтическое, Медицинское, Биологическое)
Иностранные языки Английский (Средний)
ТРЕБОВАНИЯ

Qualifications:

  • Education: Pharmacist/biochemistry/Biologist/Microbiologist

  • 3-5 years’ of experience in pharmaceutical industry in similar positions

  • Excellent communication skills

  • IT skills

  • Russian and English languages – working level

УСЛОВИЯ РАБОТЫ И КОМПЕНСАЦИИ

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.

Headquartered in Denmark, Novo Nordisk employs approximately 41,400 people in 77 countries and markets its products in more than 165 countries.

You can make the next step in your professional development in a global expanding company and get a life-changing career!

Region AAMEO (Africa, Asia, Middle East, and Oceania) is one of the main drivers of Novo Nordisk’s growth today.

BANEC (Business Area of Near East and Commonwealth of Independent States), a part of AAMEO, is a vast region that includes 20+ countries.

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Новости компании
09.06.2017 Офис в радость
Есть компании, где сразу, еще с порога, хочется остаться работать. Новый дом Novo Nordisk потрясающе влияет на настроение, эмоциональный фон, меняет подходы людей к работе. Все стало быстрее, проще, радостнее!.