Sílvia Ribeiro Email & Phone Number

Lisbon, Pt

Lisboa, Portugal

- Carry out the implementation of Quality Risk Management (QRM) in order to capture, manage, report and mitigate risks throughout product's lifecycle.- Develop, set and implement Process Validation (PV) procedures using QRM tools.- Oversee the validation status of products using Statistical Process Control (SPC) tools.- Improve the Quality System, either by including new methodologies or by standardizing and simplifying procedures and practices. - Responsible for conducting training in SPC tools and QRM.

Lisbon Area, Portugal

- Head of QRM department: Coordinating the team and managing projects.- Developing and conducting of QRM on-site trainings.- Translation of the SMEs expertise into the QRM framework and deliverables as Risk Facilitator.- Developing QRM approaches for product development, legacy products, sterile manufacturing, material management, supplier qualification and CVQ for Pharma and Biopharma industries.- Functional support in the developing of a software for Quality Risk Management (iRISK). Responsible for managing the validation of the software and for conducting on-site trainings and workshops.

Lisbon Area, Portugal

- Facilitated and performed E2E Risk Assessments for product development and CMO qualifications.- Embedded risk (QRM) and data driven (MVDA and DoE) approaches in the development of pharmaceutical and generic products.- Contributed to continuous improvement and operational excellence of Pharma Projects using QbD and Lean-6Sigma. Applied DMAIC approaches, Root Cause Analysis, DoEs and Statistical Control Charts for variability reduction.- Functional support in the developing of a software for Quality Risk Management. Enrolled in the validation of the software and the conducting on-site trainings and workshops.

Lisbon Area, Portugal

- Process Validation Engineer: Developed and executed validation protocols, risk assessments and reports for processes following the requirements of Validation Plans. Performed the technical review on other site documents such as deviations, change controls, and batch records.- Supplier Qualification Engineer: Participated in supplier approval process through the assembly and review of questionnaires, quality agreements, risk assessments and audits. Performed supplier evaluations to determine the suitability of suppliers. Maintenance of the Approved Supplier List.

Cantanhede

- Responsible for the consolidation of process data for European clients' though modelling, evaluation and optimization of integrated bioprocesses. Simulated scale-up to production scales, unit operations design and economic assessments.Achieved with the following software: SuperPro Designer, Matlab and Visio Microsoft Office.- Enrolled in the continuous improvement plan of High-performance Liquid Chromatography (HPLC) data acquisition. Including validation of methods, peak integration and optimization of an HPLC method for the simultaneous quantification of the major sugars and organic acids in a fermentation broth. Achieved with the following software: LabSolution.

Loures

Lean TechnicalPAT TechnicalEvaluation and optimization of an API production process through the collection and analysis of data using PAT and Lean-Six Sigma tools: DMAIC methodology, Multivariate Analysis, Value Stream Mapping, Statistical Process Control and the Theory of Constraints. The planning and theimplementation of improvements in the production process, including a validation of NIR spectroscopy method. The improvements implemented decrease the cycle time and led to an increase of 10% in maximum capacity of the production process per year. The evaluation gave insides to further improvements in the quality of the product.

Lisboa E Região, Portugal

160 hoursResearch project in industrial pharmaceutical field about Process Analytical Technology (PAT) Statistical Processes Control (SPC).

Integrated Master'S Degree (3+2 Msc), Biological Engineering, 17 Out Of 20

The course gave a background training in Biology, Mathematics, Physics, Chemistry and Engineering to find solutions to technical.

Biopro World Talent Campus - Phd Course In Biotechnology Manufacturing, Http://Biopro.Nu/

The course was organized by DTU in collaboration with KU and the leading biotechnology manufacturers Novo Nordisk, Novoenzymes, CP Kelco.