Izabela Rapcham Email & Phone Number

• Implementation of the Cleaning Validation program, preparing strategic documentation (PMV, SOP, Technical Memoranda, Risk Analysis and Protocols) in accordance with current legislation from ANVISA, FDA and EMA for biological products.• Validation of biological processes and auxiliary processes (membranes lifetime and chromatographic resins lifetime, holding time studies).• Equipment Qualification.• Use of the SE Suite document management system and SAP integrated system.•… Show more • Implementation of the Cleaning Validation program, preparing strategic documentation (PMV, SOP, Technical Memoranda, Risk Analysis and Protocols) in accordance with current legislation from ANVISA, FDA and EMA for biological products.• Validation of biological processes and auxiliary processes (membranes lifetime and chromatographic resins lifetime, holding time studies).• Equipment Qualification.• Use of the SE Suite document management system and SAP integrated system.• Cleaning Validation SME in regulatory agencies audits and technology transfer partners audits.• Ability to respond, act or replace coordination during vacation/absence periods. Show less

• Participation in technical technology transfer meetings for strategic definitions and problem solving in cleaning validation and process validation activities.• Equipment qualification and validation of embedded softwares.• Validation lifecycle documents creation: user requirements, risk analysis, operational procedures, plans, protocols and validation reports for processes, cleaning and equipment.

Campinas, São Paulo, Brazil

• Management of Cleaning Validation activities.• Strategic document evaluation with technical experts from global teams.• Preparation of risk analysis, Cleaning Validation and Process Validation protocols and reports.• Carrying out sampling for cleaning validation, monitoring critical steps of biological processes for Validation.• Identification of improvements in internal flows and documentation.• Equipment qualification.

Hortolândia, São Paulo, Brazil

• Preparation and execution of Cleaning Validation studies based on national and international legislation and guides (ANVISA, EMA, ICH).• Support for highly complex technical demands with the cleaning validation subject matter expert.• Expertise in audits of national and international regulatory agencies.• Support in the investigation of quality deviations, risk management, review of procedures and Validation Master Plan, change control evaluation.• Providing technical training… Show more • Preparation and execution of Cleaning Validation studies based on national and international legislation and guides (ANVISA, EMA, ICH).• Support for highly complex technical demands with the cleaning validation subject matter expert.• Expertise in audits of national and international regulatory agencies.• Support in the investigation of quality deviations, risk management, review of procedures and Validation Master Plan, change control evaluation.• Providing technical training related to the Quality System. Show less

Hortolândia, Sp

• Preparation and execution of Cleaning Validation studies based on national and international legislation and guides (ANVISA, EMA, ICH).• Project to implement TOC analyzes for Cleaning Validation, reducing cost and analysis time in validating well-established cleaning processes.• Support in the investigation of quality deviations, risk management, review of SOPs, evaluation of change control.• Providing technical training related to the Quality System.

Londrina E Região, Brasil

• Writing and reviewing GMP documents, such as SOPs and Quality Manual.• Conducting internal audits.• Applying technical training in GMP and CAPA for company employees.• Management and execution of thermal equipment qualification.• Management and execution of HVAC qualification.• Management and execution of laminar flows and biological safety cabinets certification.• Management of the preventive maintenance and calibrations schedule of equipment and instruments.

Toledo E Região, Brasil

• Analytical methods review in compliance with current U.S Pharmacopeia.

Toledo E Região, Brasil

• Development, execution and review of cleaning validation protocols in accordance with current national legislation.• Management of cleaning validation studies, definition of acceptance criteria and development of CV analytical methods.• Assessment and updating of cleaning validation protocols in response to changes in equipment, processes or products.

Toledo - Pr

• Supporting process validation activities of liquid, solid and semi-solid pharmaceutical products.• Interface for problem solving with production, quality control, pharmacotechnical development and analytical development areas, applying quality tools.• Internship project to automate documents and improve the internal flow of validation activities.

Bachelor Of Science - Bs, Pharmacy

Six Sigma Green Belt

Post Graduation, Industrial Management And Pharmaceutical Technology - Pharmaceutical Engeneering