Browse
···
Log in / Register
Job Summary: Responsible for ensuring compliance of processes and documents with Good Manufacturing Practice (GMP) guidelines, guaranteeing data integrity and traceability in regulated environments. Key Highlights: 1. Acts as a technical reference for documentation controls and data management. 2. Monitors regulatory data integrity policies and procedures. 3. Supports regulatory audits and inspections. **Mission:** Responsible for ensuring compliance of processes and documents with Good Manufacturing Practice (GMP) guidelines, ensuring data integrity, traceability, and reliability of data generated and maintained in regulated environments. Acts as a technical reference for documentation controls and data management, supporting internal and external audits. **Key Responsibilities:** * Implement and monitor data integrity policies and procedures in accordance with regulatory requirements (ANVISA, FDA, EMA). * Review and approve GMP documentation (procedures, records, protocols, and reports), ensuring compliance with internal and regulatory standards. * Conduct training on data integrity (ALCOA\+) and good documentation practices for operational and administrative teams. * Perform risk assessments related to data integrity in computerized systems and manual processes. * Monitor quality indicators related to document management and propose action plans for continuous improvement. * Participate in projects to ensure adherence to data integrity standards (ALCOA\+). * Support other Quality Systems activities to ensure timely manufacturing and release of products with quality for patients. * Support regulatory audits and inspections by providing evidence and explanations regarding data and documentation controls. **Educational Requirement** * Completed undergraduate degree or currently in the final year **Benefits** * Salary advance * Medical assistance * Dental assistance * Food allowance * Meal voucher * Gympass (Wellhub) * Career development plan Employment type: Permanent CLT
