QA Manager - Qualified Person - 728986

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QA Manager - Qualified Person

Copenhagen

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The purpose of the QA Manager – Qualified Person role is to ensure that marketed medicinal products and investigational medicinal products are manufactured and distributed in accordance with GMP/GDP and also that all complaints and quality issues related to importation and distribution of Novartis products in Denmark are handled in accordance with GMP/GDP legal, regulatory requirements legal and the Novartis Corporate Quality Manual.

Key Responsibilities:

Ensure that handling and distribution of medicinal Novartis products are in accordance with regulatory requirements, GMP/GDP and the Novartis Corporate Quality Manual (QM) and Policies.
Perform batch review/release of commercial products. Reject non-compliant batches as required. Ensure that CoA and other documents are received, reviewed and archived for all batches released for sale or distribution to clinical trial sites.