Blau Farmacêutica is hiring a Quality Assurance Analyst to join our team. In this role, you will focus on managing and supporting change control processes to ensure compliance with Good Manufacturing Practices (GMP) and support the broader Quality Assurance department.
What You'll Do
- Manage and monitor changes with impacts on GxP.
- Support areas in the correct opening and conduction of changes.
- Conduct technical discussion meetings, regulatory framing, approval of Change Management (CM), and monitor the change process.
- Evaluate risk analyses related to the change control process.
- Prepare and review documentation related to the quality system to comply with Good Manufacturing Practices (GMP).
- Monitor internal and external inspections and audits based on current technical and legal documents, ensuring compliance.
- Evaluate data, preparing and analyzing technical documents to provide continuous improvement of processes.
- Participate in the elaboration and revision of Quality Risk Management.
- Conduct training related to Good Manufacturing Practices.
- Assist in conducting GAP Analysis of new legislation.
- Assist in technical activities performed by the Quality Assurance department.
What We're Looking For
- Complete graduation in Pharmacy.
- Mastery of quality tools (essential), including FMEA and the SE Suite system.
- Experience in Change Control management.
- Knowledge of Quality Risk Management.
- Experience in the pharmaceutical industry.
Nice to Have
- Active CRF (Pharmacy Council Registration) desirable.
- Experience in injectable production desirable.
Technical Stack
- FMEA
- SE Suite system
Work Mode
This is an onsite position located at Rodovia Raposo Tavares, KM 30,5 - Cotia.
Blau Farmacêutica respects and supports diversity and does not discriminate based on race, religion, gender identity, sexual orientation, disability, or age at any stage of the selection process.
