Manager - Quality Risk Management

Quality Risk Management:

1. To establish, identify, assess, record, prioritize, communicate, and manage the risks associated with quality and compliance during design/development, manufacture, and distribution of drug products for human use.

2. To perform risk assessment and ensure its mitigation for emerging risks such as Nitrosamines/NDSRIs.

3. To execute gap assessment for the emerging regulations and notifications (Regulatory updates) from the regulatory agencies worldwide and perform quality risk management process to ensure compliance to the requirements.

4. Review the Quality risk management (QRM) documents executed by different stakeholders for its completeness and effectiveness and suggest the action plan based on the gap assessment of these documents.

Documentation Compliance:

1. Review and Approval of SOPs, protocols, reports, and other documents.

2. To ensure effective control of confidential documents pertaining to risk office.

People Management including technical training:

1. To impart training pertaining to quality risk management and office of risk & compliance processes to relevant stakeholders.