Supplier Quality Auditor

**Site Name**: India - Maharashtra - Worli Mumbai
**Posted Date**: Jan 27 2025
**Job Purpose**:
The purpose of this job role is to assure that material and service suppliers within the scope of SQ A&C meet applicable GSK and Regulatory requirements.

This is delivered by:

- ** Execution of documented assessments of the compliance status of assigned suppliers.**:

- ** Management of supplier CAPA plans to close identified gaps resulting from said documented assessments.**:

- ** Maintenance of audit and user site data for assigned suppliers in GSK supplier management system.**:

- ** Interfacing with the supply base while providing an “inward facing” contact with designated GSK site(s) to ensure effective management of supplier issues.**:
**Key Responsibilities**

**Supplier assessment, approval & compliance**
- ** Responsible for performing Quality System assessments/audits of assigned suppliers within role scope; making a risk-based recommendation on the GMP approval status of the supplier (including proposals about the continued use of suppliers with marginal compliance, as applicable) and documenting the assessments/audits in the relevant systems within the targeted timelines.**:

- ** Responsible for agreement of appropriate corrective and preventive action (CAPA) plans with suppliers and follow-up on the completion of agreed CAPAs within agreed timelines.**:

- ** Responsible for ensuring that all audit related documentation is communicated out within the targeted timelines and that CAPA related documents are reviewed and responded to within targeted timelines.**:

- ** Responsible for performing agreed For Cause/Target audits to support supplier complaint investigations / supplier changes for significant quality incidents at supplier sites.**:

- ** Responsible for maintenance of “auditee” (supplier) profiles in the relevant data systems and ensuring that all data associated with the supplier assessment and user sites are kept current based on currently available information provided.**:

- ** Responsible for completing actions associated with supplier change controls / change notifications and supporting the Quality Assurance Agreements (QAAs) for assigned suppliers, as appropriate.**:

- ** Responsible for leading and/or supporting the management of third party audits performed by auditing firms and/or contract auditors performing audits on behalf of GSK as required to ensure process compliance and the quality of the supplier audit, as assigned.**:
**Risk Management**
- ** Responsible for collating identified risks and escalating high risk issues/situations to ensure management and stakeholders understand the technical, regulatory and quality risks and that appropriate mitigating actions are identified.**:
**R**egulatory / Customer inspection support**
- **Responsible for providing relevant support to GSK sites undergoing regulatory/customer inspections, as assigned.**:
**Supplier assessment, approval & compliance**
- ** Responsible for performing Quality System assessments/audits of assigned suppliers within role scope; making a risk-based recommendation on the GMP approval status of the supplier (including proposals about the continued use of suppliers with marginal compliance, as applicable) and documenting the assessments/audits in the relevant systems within the targeted timelines.**:

- ** Responsible for agreement of appropriate corrective and preventive action (CAPA) plans with suppliers and follow-up on the completion of agreed CAPAs within agreed timelines.**:

- ** Responsible for ensuring that all audit related documentation is communicated out within the targeted timelines and that CAPA related documents are reviewed and responded to within targeted timelines.**:

- ** Responsible for performing agreed For Cause/Target audits to support supplier complaint investigations / supplier changes for significant quality incidents at supplier sites.**:

- ** Responsible for maintenance of “auditee” (supplier) profiles in the relevant data systems and ensuring that all data associated with the supplier assessment and user sites are kept current based on currently available information provided.**:

- ** Responsible for completing actions associated with supplier change controls / change notifications and supporting the Quality Assurance Agreements (QAAs) for assigned suppliers, as appropriate.**:

- ** Responsible for leading and/or supporting the management of third party audits performed by auditing firms and/or contract auditors performing audits on behalf of GSK as required to ensure process compliance and the quality of the supplier audit, as assigned.**:
**Risk Management**
- ** Responsible for collating identified risks and escalating high risk issues/situations to ensure management and stakeholders understand the technical, regulatory and quality risks and that appropriate mitigating actions are identified.**:
**R**egulatory / Customer inspection support**
- **Responsible for providing r