**Major Accountabilities

• Responsible for the preparation of documents required through the complete lifecycle of a supplier such as but not limited to the Supplier Initial Quality Questionnaires (QQ), Quality Assurance Agreement (QAA) and Quality Risk Assessment (QRA), as per agreed third party products in accordance with company and regulatory requirements, as per internal and external guidance.

• Responsible for the Audit CAPA Plan uploading and actions follow up with Suppliers.

• Responsible to draft and submit Audit Request Change Form.

• Support and guide risk experts to evaluate and complete third party Risk Assessment for suppliers within defined timelines.

• Responsible for writing and updating applicable SOPs. • Monitor KPIs agreed with the customer on each deliverable.

• Responsible for scheduling meetings with the team/quality manager to determine and assign follow-up action items, if required.

• Support QA Manager responsible for the review of documentation required through the complete lifecycle of a supplier such as QAA and QRA to ensure compliance with Novartis requirements.

• Communicate with internal stakeholders or third parties as required

**Key Performance Indicators

• Manage Quality aspects and projects within the area.
• Applicable process KPIs and KQIs.

• Partner satisfaction/responsiveness.

• Adherence to projects timelines and proactive management of upcoming issues.

• Generation/delivery of reports related to owned activities.

• No issues due to non-observance of cGMP, SOPs and no critical deviations/findings

**Work Experience
• At least 3 years in the Pharmaceutical Industry or similar.

• Solid experience in data analysis and reporting.

**Skills

• Quality Assurance

• Continuous Improvement

• Good Manufacturing Practices

• Local/international Health Regulations

• Solution oriented behaviour

• Self organization

• Stakeholder Engagement

• Effective communication

**Language
• English

• Portuguese, according to needs