Company: Novartis India Ltd
Location: Mumbai
Minimum Requirements
What you’ll bring to the role:
- Postgraduate in Life Sciences or Pharma
- Knowledge of the cGMP/GDP/QMS, ICH guidelines
- Knowledge of quality for pharmaceuticals, medical devices, and human cell therapy/gene therapy products
- Knowledge of HSE regulation and Novartis HSE requirements
- 1 to 3yrs of experience in quality assurance activities in the pharma domain
Your key responsibilities:
Your responsibilities include, but are not limited to:
- Support management of document-based GMP compliance inspection and Regulatory compliance with the registered dossiers of Novartis Japan. Support Quality responsible person for Novartis Pharma Japan.
- Ensure timely collection of required documents and information for document-based GMP compliance inspection of manufacturing sites registered in Japan. Efficient communication with relevant stakeholders and manufacturing sites in a timely manner.
- Support the following regulatory compliance activity under GQP/QMS Work together with other line functions to keep the compliance of Japan approval files for the products. Effective communications with manufacturing sites.
- Change control related to GMP compliance inspection. Support projects of newly launched products and product transfer. GMP compliance inspection information. Collection of the required information and sharing with relevant stakeholders, efficient handling of information and management of critical information.
- Cooperation with Novartis Japan NCQ members. Status monitoring and trend of document collection timelines. Report to Quality Assurance Supervisor in Japan
- Review collected documents and contents checks. Ensure that a timely, effective, continuous quality improvement in corroboration with relevant stakeholders. Fulfill the responsibility of Document Management and required Education & Training.
- Support projects of new product launches and product transfer. Provide support for the preparation and follow-up of GMP inspections at Country Japan.
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