Manage the quality document system, review procedures impacting good manufacturing practices - SOPs, Manufacturing Orders, Quality Control Procedures, Environmental Monitoring Forms, Validation Test Protocols, etc. Provide input on quality deviations, non-compliance, and action plans; escalate to supervision and management as necessary according to the quality manual. Open Change Control and manage actions, assessing the criticality and impact of the changes. Develop and/or review risk analyses for production areas with environmental monitoring, identifying and implementing actions to mitigate risks.

Validation of decontamination processes using hydrogen peroxide. Performance verification of classified areas. Risk analysis for the release of classified areas. Risk assessment for environmental monitoring of classified areas. Daily training of analysts and operators in validation, sanitization, and sampling processes. Daily assessment of compliance of environmental monitoring samples. Daily verification of sanitization processes, sampling, material flow, and aseptic behavior in classified areas to ensure adherence to operational procedures. Development of inputs on processes and production activities impacting environmental monitoring. Evaluation of gowning process with A/B grade clothing. Support in SOP review in the electronic quality system (Veeva). Support in systematic deviation investigation using A3 tool (SPS - Systematic Problem Solving). Support in implementing Change Controls (CR - Change Request).

Preparation of aseptic filling validation reports (Media Fill) every 3 months (2 production lines) through analysis of environmental monitoring results, microbiological, and physico-chemical tests. Training of production and laboratory staff in aseptic filling validation. Monitoring 3 validation lots for holding time in the production area to ensure process execution and sample collection as per the protocol. Monitoring cleaning validation in the production area to coordinate operator activities, supervise cleaning execution, and ensure proper sample collection. Quarterly analysis of results of pure steam and water for injection (WFI) systems. Opening and investigating non-conformities through an electronic system for root cause analysis (5 whys, Ishikawa Diagram). Opening and executing Corrective and Preventive Actions (CAPA). Reviewing operational procedures related to process validation for continuous improvement to reflect executed processes, comply with current legislation, and progressively incorporate international guidelines (PIC/s, EMA, and FDA). Study of pharmacopoeias, references, and international guides (USP, ISPE, ECA, and PDA) on visual inspection of sterile products to define inspector qualification strategy (Visual Inspection). Preparation of the inspector qualification protocol, planning dates and necessary materials, preparing the qualification kit (Knapp test), training personnel, executing the test, completing result annexes, and preparing the report. Result: first company inspector qualification carried out over a month of testing, qualifying 16 employees across different shifts and schedules.

Preparation of risk assessment for distribution routes in Latin America, meeting ANVISA requirements through thermal data analysis and comparison with product stability studies to ensure low probability of conditions worse than those in stability studies. Gap analysis of current procedures by comparing them with regulatory legislation. Management of Change Controls and CAPAs through the electronic system Trackwise. Reviewing Analysis Instructions (Physical-Chemical and Microbiological) as per reference methodologies. Elaborate Product Periodic Review Reports by collecting batch data, analyzing critical quality attributes and critical process parameters trends, and verifying process capability. Managing the lifecycle of controlled documents (Manufacturing and Packaging Instructions, Logbooks, Operational Procedures, Work Instructions, etc.). Preparing data integrity training materials. Managing analytical software to ensure data integrity of electronic systems (User profiles, access permissions, audit trails, data backup).

Daily execution of microbiological tests, including ELISA, hemadsorption, hemagglutination, and biological potency. High demand for test execution and release due to the yellow fever outbreak. Preparation and maintenance of cell culture twice a week in a level II biological safety cabinet. Microscopic analysis of cell culture on the 14th and 21st days of incubation. Responsible for planning materials and supplies needed for cell culture activities. Training in Good Laboratory Practices and Biosafety.

Ensaios pré-clínicos para avaliação de potencial efeito terapêutico do extrato de romã para tratamento de leões cutâneas e para crescimento capilar. Preparo e execução dos testes em modelo animal, estudo de estruturas celulares para análise microscópica, compilação e análise de resultados.

Literature research and preparation of scientific material on the indications, administration, and efficacy of medicinal plants. Database search (PhactMI Drug Information Database), data compilation and critical analysis for creating an application on the prescription, drug interactions, and adverse effects of medicinal plants included in the Memento Fitoterápico.

Analysis of biological samples from clinical trials of bioequivalence study for regulatory registration with ANVISA.Processing samples and extracting the substance of interest.Preparation of solutions and analytical standards for control curve.Analysis using HPLC-MS and interpretation of results (detection limits, standard and bioanalytical curve, intra-run and inter-run variations).Participation in internal audits.Handling various laboratory equipment: pipettes, dispensers, balances, pH meters, centrifuges and microcentrifuges, sample concentrators, etc.Receiving, storing, and controlling temperature of samples.