Executive-complaint Hub

2 months ago


Mumbai, India Novartis Full time

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently.
- Your key responsibilities:

- Your responsibilities include, but 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 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.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**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 pharma domain

Why Novartis?
- 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
- We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you could do here at Novartis
- Accessibility and accommodation-
**Division**
- Novartis Technical Operations

**Business Unit**
- QUALITY

**Country**
- India

**Work Location**
- Mumbai

**Company/Legal Entity**
- Nov Hltcr Shared Services Ind

**Functional Area**
- Quality

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No


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