Development Quality Assurance Specialist

NOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNL. SAN. VE TİC. A.Ş.

Job Description

The Development Quality Assurance Associate provides quality oversight for activities under-taken in a country to assure compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines to assure the execution of high quality research and activities within a country. Activities in scope include but may not be limited to assuring adequate systems are in place for the protection of patient safety, rights and well-being, data integrity, oversight of local Investigational Medicinal Product (IMP) release, and quality oversight of Clinical and Pharmacovigilance activities as needed in both pre- and post- market settings in assigned country(ies).
The Development Quality Assurance Associate is responsible for assuring the quality and compliance of Global Drug Development (GDD), Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs. Operates in direct collaboration with local GDD colleagues (Clinical Operations, Patient Safety and Regulatory Affairs), Medi-cal Affairs and Country QA to ensure compliance to Novartis requirements and relevant HA regulations and guidance. Ensures implementation of the Novartis Quality Manual and Quali-ty Management System in assigned country(ies) to achieve a high level of quality and com-pliance.

Minimum requirements

Degree in Life Sciences (preferably pharmacy or chemistry)

English fluent in speaking and writing.

Min. 2 years experience in the pharmaceutical industry in a relevant field such as quality assurance, registration, clinical development or a directly related area.