Compliance scientist

Sep 27, 2021

Job Description

5-7 products manufactured at the Puurs site. A compliance scientist typically is responsible for regulatory compliance life cycle management of these products. If your’re also involved in a new product, you’ll oversee the QA aspects of the new product throughout the full process from first transfer steps into the site until commercial launch in up to 80 countries.

Your responsibilities:
Your responsibilities include, but are not limited to:

• Responsible for regulatory compliance, you play an important key role to ensure product of the requested quality is delivered to our patients. Only after regulatory approval, which is required for every individual country, a product can be delivered to the concerned markets and this is needed to allow the treatment of patients with our pharmaceutical products.
• Liaison between Reg CMC, R&D and NTO Puurs site departments. Main responsibilities are supporting regulatory submissions, Health Authority Questions, and ensuring regulatory compliance through the implementation of registered information (CPDS, LIMS).
• Within the general responsibilities of QA Compliance, the specific responsibilities of this QA Compliance Specialist are: supporting QA Compliance related launch and post-approval activities (post-approval changes, transfers of new products, regulatory compliance support for changes, remediation, divestment, pruning and due diligence) of the site specific products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements

Minimum Requirements

Novartis Technical Operations
Full Time

Compliance scientist

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