Quality Control Analyst - Sterile Injectables Center

Description

Job Summary: Quality Control Analyst responsible for physicochemical and microbiological analyses of the water system used in the production of sterile injectables, ensuring compliance with regulations and Good Manufacturing Practices. Key Highlights: 1. Ensures microbiological safety and integrity of the production process. 2. Responsible for water analysis for sterile injectables. 3. Works in a regulated environment under Good Manufacturing Practices. As a **Quality Control Analyst**, you will be responsible for performing and monitoring physicochemical and microbiological analyses of the water system used in the production of sterile injectables, ensuring compliance with RDC 67/2007, the Brazilian Pharmacopoeia, applicable international compendia, and Good Manufacturing Practices. This is a critical position for product microbiological safety and for maintaining production process integrity. ### **Responsibilities** * Perform periodic sampling at critical points of the water system. * Conduct physicochemical analyses according to current specifications. * Perform applicable microbiological analyses. * Evaluate results against alert and action limits. * Conduct trend analysis. * Record data ensuring integrity and traceability (ALCOA+). * Report out-of-specification results and support investigations. * Assess potential impact on manufactured batches. * Monitor sanitizations, maintenance, and requalifications. * Support qualification activities (IQ, OQ, PQ). * Prepare periodic system performance reports. * Maintain documentation readiness for audits and inspections. ### **Requirements** * Completed or ongoing undergraduate degree in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, or related fields. * Knowledge of the Brazilian Pharmacopoeia (purified water). * Basic understanding of physics, mathematics, and chemistry. * Prior experience in a Quality Control laboratory. **Desirable:** * Experience with water production systems. * Experience working in a regulated environment. * Experience with microbiological and physicochemical analyses. ### **Additional Information** * On-site work in Ipatinga/MG; * Flexible working hours.