Associate, Commercial GMP QA

Jun 01, 2021

Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

1. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
2. 100% timely delivery of all training requirements including compliance
3. Manage the following regulatory compliance activity under GQP/QMS Work together with other line functions by receiving necessary advice from other NCQ member to keep the compliance of Japan approval files for the products
Oversight GMP manufacturing sites from GQP point of view
Entering into quality agreement with manufacturing sites, business partners and maintain it
Change control related to product quality
Timely management of periodic regulatory compliance check including APQR review
Timely management of periodic GMP inspection certification for Novartis products related manufacturing sites and others
Update existing system and process reflecting new requirements from HA and others
4. Quality improvement - Contribute continuous quality improvement in collaboration with relevant business units, manufacturing sites and others
5. Support projects such as new product launch, product transfer, global and/or local initiatives
6. Contribute to operational integration with Sandoz Japan for operational excellence and simple operation
7. Ensure appropriate interface with authorities for any GxP related activity and provide individual responsibility as a SPOC for health authority if requires.

Minimum Requirements

Novartis Technical Operations
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Associate, Commercial GMP QA

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