Quality Assurance Assistant - Injectable Compounding Center

Description

Job Summary: Support the maintenance and implementation of the Quality Assurance System in the laboratory, controlling documents, traceability, and providing support for qualifications and audits. Key Highlights: 1. Support quality management in the injectable compounding laboratory. 2. Control quality documentation and traceability of technical records. 3. Support qualification, validation, and audit activities. In this role, you will be responsible for supporting the maintenance and implementation of the Quality Assurance System in the Injectable Compounding Laboratory, ensuring document control, traceability of technical records, and support for qualification, validation, and audit activities, in compliance with RDC 67/2007 and applicable Good Practices. ### **Responsibilities** * Control the issuance, review, distribution, retrieval, and archiving of Quality documents. * Verify production batch and Quality Control documentation prior to archiving. * Support deviation, non-conformance, and corrective and preventive action (CAPA) management. * Control schedules for qualification, calibration, and maintenance of critical equipment. * Update technical training records, ensuring traceability. * Organize raw material certificates and internal/outsourced analytical reports. * Support internal and external audits as well as sanitary inspections. * Ensure integrity, legibility, and traceability of documented information. ### **Requirements** * Technical or undergraduate degree in Chemistry, Pharmacy, Biotechnology, or related fields, completed or in progress. * Familiarity with SOPs, CAPA, change control, and deviations. * Basic knowledge of technical documentation and traceability (Excel). * Proficiency in reading and writing, with ability to draft clear, objective reports, records, and communications in accordance with internal and regulatory standards. * Prior experience in laboratory quality control or document management is desirable. **Additional Information** * On-site work in Ipatinga/MG; * Flexible working hours. Here, you will join a team that values **collaboration**, **continuous learning**, and the pursuit of **exceptional results**. Together, we transform needs into innovative and customized solutions!