Quality Assurance Coordinator

Description

Job Summary: Pharmacist professional to work in quality control, performing analyses, validations, and laboratory management of pharmaceutical products. Key Highlights: 1. Technical review and release of microbiological and physicochemical analyses 2. Investigation and resolution of analytical problems 3. Implementation and qualification of new assays and methodologies **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 problems, with technical decision-making regarding critical results;** **Research, implementation, and qualification of new assays, methodologies, and laboratory equipment (HPLC, TOC, conductivity, bioburden, stability, among others);** **Management of routine laboratory activities, 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 of 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 documentary 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 medications;** **Experience in process and environmental control validations;** **Knowledge of regulatory standards (RDC 67/2007, Brazilian Pharmacopoeia, Good Manufacturing Practices);** **Experience in quality document control;** **Ability to make technical decisions regarding critical results.** **Audit support.** **Education:** **Bachelor's degree in Pharmacy.** **Postgraduate studies in Quality Control, Microbiology, Validation, or related fields are desirable.** **On-site position in Pedro Leopoldo - MG.** **Fixed salary + benefits + development plan.** Employment Type: Full-time Benefits: * Medical insurance * Dental insurance * Fuel allowance * Commercial agreements and discounts * Meal allowance * Transportation allowance Selection Questions: * 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