Quality Assuarance & Regulatory Affairs specialist

İşin təsviri

Quality Assuarance & Regulatory Affairs specialist, Azerbaijan, Baku

Job location

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.

Are you ready to make the next step in your professional development in a global expanding company?

Join Novo Nordisk region SEEMEA BAMEAC and get a life-changing career!

BAMEAC, a part of SEEMEA, is a vast region that includes 73 countries with 1500 plus employees. The business area office is in Istanbul.

About the department

You will join a team of highly skilled professionals responsible for business in Commonwealth of Emerging Markets (CEM): Kazakhstan, Azerbaijan, Georgia, Uzbekistan, Turkmenistan, Tajikistan, Kyrgyzstan and Mongolia. You will report to the Country Manager Azerbaijan and be located at Baku.

The position

In the role of Quality Assurance & Regulatory Affairs specialist, you will ensure Quality Management System, Regulatory Affairs and Compliance in affiliate is in compliance to NN and external requirements in Azerbaijan.

Nature and scope of Main accountabilities

Quality Assurance:

• Document control and distribution responsible:
• Azerbaijan QMR Responsible.
• Internal Audits / External Audits
• Training and quality competency development across the Azerbaijan Affiliate
• One-point contact in Azerbaijan on quality issues
• One-point contact for change control and deviation processes in Azerbaijan
• Inform and keep update the local management on quality issues
• Review and approve major changes in quality agreements with distributors
• Product Release Responsible for Azerbaijan
• Maintaining the overview of local external quality requirements applicable to Azerbaijan.
• Repackaging & Archiving responsible

Regulatory Affairs:

• Carries out the process of new registration according to marketing plan, local rules and regulations for registration and relevant Novo Nordisk policies Recruitment of standard files: compiling of standard files for submission, submission of documentation to authorities
• Maintains existing registration including updates in accordance with NNAZ schedules
• Carries out the re-registration process
• Order the samples and standards for registration/re-registration
• Handling of registration samples and reference standards
• Maintenance of Labeling issues
• Proofreading
• Keeps track on local legislation and regulations
• Promotional material approval
Pharmacovigilance back up/Compliance Coordinating

Qualifications

• University degree
• 6 years of experience in QA/RA
• Command of English and Russian would be an advantage
• Experienced MS Office user

Deadline:

20 April 2020, interested candidates could send CV to [email protected] with vacancy name in the subject.

At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.

Novo Nordisk tərəfindən digər vakansiyalar

• Product Manager
• Administrative assistant
• Tibbi nümayəndə
• Commercial Manager Insulin & Rare Disease
• Product Manager