Quality Assurance Coordinator

Description

Job Summary: Professional to perform technical review and release of microbiological/physicochemical analyses, laboratory management, and audit support. Key Highlights: 1. Experience in quality control analysis of sterile pharmaceuticals 2. Involvement in process, cleaning, and environmental monitoring validations 3. Knowledge of regulatory standards and quality document management **On-site position in Pedro Leopoldo - MG.** **Responsibilities and Duties:** **Technical review, critical evaluation, and release of microbiological and physicochemical analysis results for injectable products and raw materials;** **Monitoring and review of tests on finished hormonal and non-hormonal products, including evaluations using syringes, needles, and IV bags;** **Investigation and resolution of analytical issues, with technical decision-making in response to critical results;** **Research, implementation, and qualification of new assays, methodologies, and laboratory equipment (e.g., HPLC, TOC, conductivity, bioburden, stability);** **Management of daily laboratory operations, including activity planning, control of supplies and consumables, and monitoring of equipment calibrations and qualifications;** **Development, revision, and control of protocols, microbiological and physicochemical validation reports, SOPs, and other quality documents within the department;** **Direct involvement in process, cleaning, media fill, and environmental monitoring validations;** **Technical support during health inspections and audits, ensuring compliance with current legislation and document traceability;** **Preferred Qualification: Experience in analytical validations, such as assay, impurities, identification, and execution of physicochemical analytical assays.** **Requirements and Qualifications:** **Solid knowledge of quality control analyses, preferably in sterile pharmaceuticals;** **Experience in process and environmental control validations;** **Familiarity with regulatory standards (ANVISA RDC 67/2007, Brazilian Pharmacopoeia, Good Manufacturing Practices);** **Experience in quality document control;** **Ability to make technical decisions in response to critical results.** **Audit support experience.** **Education:** **Bachelor’s degree in Pharmacy.** **Postgraduate degree in Quality Control, Microbiology, Validation, or related fields is desirable.** **On-site position in Pedro Leopoldo - MG.** **Fixed salary + benefits + development plan.** Employment Type: Full-time Benefits: * Medical assistance * Dental assistance * Fuel allowance * Partnerships and commercial discounts * Meal allowance * Transportation allowance Selection Question(s): * This is an on-site position in Pedro Leopoldo - MG. Are you available to work on-site in Pedro Leopoldo? * Please state your most recent salary and benefits. * A Bachelor’s degree in Pharmacy is required. * Do you have experience in analytical validations, such as assay, impurities, identification, and execution of physicochemical analytical assays? Work Location: On-site