Executive-complaint Hub

5 months ago

Mumbai, India Novartis Full time

Executive-Complaint Hub
Location - Mumbai #LI Hybrid
About the Role:
Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems
Key Responsibilities:

- 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**:

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

**Minimum requirements**

Essential Requirements:

- 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


**Division**

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**

Yes

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