Marcelle Balaro Email & Phone Number

Duque De Caxias, Rio De Janeiro, Brazil

⊛ Legislation Impact Analysis ⊛ Assistance in creating a Declaration of Conformity ⊛ Monitoring the Manufacturing Process ⊛ Assistance in the Technical Documentation of products ⊛ Change Management ⊛ Roughness Test ⊛ Responsible for the area's action plan (Focal Point)⊛ Risk management⊛ Troubleshooting⊛ Development of new projects ⊛ Achievement of goals set by the company⊛ Assistance in audits

⊛ Responsible for bibliographical research, literature review, production of theoretical references, monitoring of climatic chambers, opening of CM (change control), stock control and purchase requisition ⊛ Pharmacotechnical development of new products and reformulation of the portfolio ⊛ Preparation of protocol and stability report, being responsible for critical analysis of results ⊛ Creation of standard procedures (SOP) and training for reorganization of the sector in accordance with GMP ⊛ Small and medium scale manipulation

Rio De Janeiro, Brazil

⊛ Creation of protocol, report and statistical treatment of results with Minitab system ⊛ Cleaning sampling and sampling for packaging and process ⊛ Responsible for material purchase requests ⊛ Participation in monitoring manufacturing processes, assistance in defining parameters and investigating deviations ⊛ Assistance in process control testing and preparation of risk analysis with FMEA tooling ⊛ Implementation of new equipment in production, assisting in the development of the procedure and validation of cleaning and process

⊛ Responsible for granulometry testing ⊛ Participation in monitoring during the manufacturing processes of solid medicines ⊛ Participation in troubleshooting ⊛ Assistance in making CPV (continuous process verification) and opening CM (change control) ⊛ Experience with statistical treatment to remove result using the Minitab system

⊛ Validation of analytical methods: • Responsible for stock control, inventory analysis and preparation of solutions for HPLC • Participation in forced degradation studies of medication and use of HPLC • Assistance in retrieving results and preparing forced degradation study reports • Assistance in precision tests to validate analytical methods ⊛ Pharmaceutical Equivalence: • Responsible for sending material to other research centers and stock control • Participation in dissolution profile studies ⊛ Drug Stability: • Responsible for preparing solutions for HPLC, dissolution tests, average tablet weight test, hardness test, Karl Fischer moisture test and desiccation loss test • Critical analysis to obtain results in spectrophotometry and HPLC • Participation in the control and monitoring of climatic chambers

Rio De Janeiro, Rio De Janeiro, Brazil

⊛ Responsible for preparing and counting cell culture, preparing cryopreservation solutions and solution medium ⊛ Assistance with weighing material and organizing stock

Lato Sensu Post-Graduate, Pharmaceutical Industry - Concepts, Applications And Activities

Bachelor Of Pharmacy, Pharmacy

English, English As A Second Language

Complete High School