Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Senior Executive - NCQ
Job Description
• 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 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 new launched product and product transfer. GMP compliance inspection information. Collection of required information and share 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. Fulfil the responsibility of the Document Management and required Education & Training.
• Support projects of new product launch and product transfer. Provide supports for the preparation and follow-up of GMP inspections at the Country Japan.
Candidate Profile
• 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 3 yrs of experience in quality assurance activities in pharma domain
Additional Information
Experience : 1 to 3 yrs
Qualification : Postgraduate in Life Sciences or Pharma
Location : Mumbai
Industry Type : Pharma
Functional Area : Quality
End Date : 30th December, 2022
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