JOB DESCRIPTION

Maintain the operation of the Quality Management System (QMS) throughout the organization;

➢ Implement, maintain, and critically review procedures, documents, and system and operational records issued by the QMS.

➢ Feed data into spreadsheets and reports related to the QMS, aiming at monitoring, analysis, actions, and communication across all areas.

➢ Support Management and the Board regarding QMS goals and actions to ensure timely measures are taken.

➢ Provide technical assistance to employees on QMS-related matters (questions about ISO 9001/API Q1 standards, procedures, records, among other topics);

➢ Promote and create awareness of the Quality Policy and Quality Objectives / Indicators.

➢ Conduct training sessions for employee qualification and development in topics within the scope of the QMS area. Evaluate the effectiveness of the training provided and maintain appropriate records.

➢ Monitor the progress of corrective actions, preventive actions, and customer complaints, encouraging their timely and effective completion;

➢ Lead the internal and external quality audit process, compile and share the results obtained.

➢ Be responsible for the external audit process (maintaining information on the API website such as non-conformities, audit planning and logistics).

➢ Communicate with suppliers, conduct technical visits to companies and service providers for the correction of non-conformities or for the development/qualification of new products, tests, and services.

➢ Prepare and issue analysis and test certificates requested in PITs or by the development area for internal and external customers;

➢ Develop laboratory test procedures when requested by coordination, based on technical standards.

➢ Specify laboratory machines and equipment to meet the requirements of internal and external customers. Request maintenance of laboratory machines and equipment;

➢ Provide support to internal and external customers to clarify questions regarding procedures and test results performed in the laboratory;

➢ Assist the continuous improvement coordination in activities related to continuous improvement projects.

➢ Perform other responsibilities and duties related to the role, as assigned by immediate leadership.