Marcia Preda, Mba Email & Phone Number

State Of São Paulo, Brazil

São Paulo, São Paulo, Brasil

Responsável pelo QMS, auditorias internas e externas, e líder da unidade de negócios de validação.

São Paulo

Validation business unit leader responsible for project and people management, prospecting clients for future projects. Reporting to the CEO. Team of three validation analysts.• Managed five projects in four multinational Pharmaceutical Industries, including serialization of packaging lines, commissioning of utilities, qualification, and CSV of laboratory equipment. Qualification of productive equipment.• Led staffing plan for the project’s execution, consulting proposals by establishing the technical scope, price, and schedule, and project progress tracking by the deliverables management and financial billing.

São Paulo

Validation leader and member of the Manufacturing Executive Committee. Responsible for managing the site business strategy and technical agenda. Reporting to the Manufacturing Site Head and dotted line with the Global Validation Director. Team of six employees.Quality Unit leader (short-term assignment) including quality control laboratories, quality assurance, training area, GMP library, retention samples, manufacturing tickets control, and quality metrics and compliance. Reporting to the Global Quality Director. Team of 36 employees (laboratory, external audit, and compliance coordinators, and quality representatives).• Led the project of closing manufacturing in Brazil and technological transfer to Puerto Rico and Spain, managing nine workstreams (people, operations, technology transfer, regulatory, decommissioning, legal, documentation, finance, and supplies). Project implemented within the time and budget expected, including the generation of technical data, submissions, and regulatory approvals, and receipt of the first imported batch. • Performed a strategy change to avoid opening a branch in the logistics operator, saving USD 600 K in SAP design, eliminating the need of a structure of six people in the logistics operator, maintaining outsourced responsibilities, and simplifying product import and release.• Conducted the adequacy project to RDC No. 430/2020 of Good Distribution Practices, impacting the distribution solution definition and seeking the lowest cost and compliance with regulatory requirements.• Led a Serialization Project with six workstreams, three international packaging sites, 53 SKU, and an outsourced logistics center. Senior management influence to continue the project under the need for real implementations and investments, and upon a legal uncertainty. Based on trend analysis and benchmarking, the strategic decision was fundamental to meet the legal deadline.• Implemented the SafeStart program with safety culture improvement.

São Paulo

Validation and process engineering leader. Reporting to the Manufacturing Site Head and dotted line to the Global Validation Services Director and Global Process Engineering Director. Team of 12 employees.• Implemented the process engineering department in the Brazilian affiliate, reorganizing people structure with division into Process engineers and Validation representatives according to their competencies and skills. Ensured compliance with global requirements. Created procedures, processes, job descriptions, and career plans.• Led the Packaging area retrofit with a total investment of BRL 5 million in equipment. Ensured training of the people involved and transfer of the knowledge acquired in the qualifications and validations to the operation, engineering, and quality. Equipment acquisition, commissioning, qualification, and packaging validation were carried out within the planned time and budget, achieving results within the quality acceptance criteria.

São Paulo

Leader of the validation area. Reporting to the Director of Manufacturing and dotted line with the Director of Global Validation. Team of nine employees.• Voluntarily prepared Business Cases for local medicines production. Upon confirmation of the financial return, technology transfer was approved, and local manufacturing products were maintained. This strategic decision generated a financial benefit, delaying the site closing by at least ten years.• Performed technology transfer for coated tablets produced by wet granulation and local packaging of chilled products in partnership with Global Molecule Steward. New tablet press and coating machines acquisition, qualification, and validation leadership. • Implemented two new cleaning agents and microbiological acceptance criteria in Cleaning Validations, improving process reliability.• Ran the Six Sigma program and sponsored several projects, receiving Green Belt Certification training for the team. The main six sigma projects implemented were: changing the import process from air to ocean, saving USD 800 K/year; implementing electronic data collection for Annual Product Review (APR), reducing 0.21 FTE (full-time employee); reducing complaints of broken capsules from 80/year to 1/year.• Assessed and developed the team's technical competencies to have at least one backup for each activity, reducing the risk of work interruption, raising a collaborative spirit, and increasing team motivation by learning.• Implemented a workflow and electronic repository system for qualification and validation protocols. Review and approval time was reduced by 75%, and documents became immediately available to be presented in audits.

São Paulo, São Paulo

Leader of the technical services area. Reporting to the Director of Manufacturing and dotted line to the Director of Global Technical Services. Team of ten employees.• Two new cleaning agents and microbiological criteria in cleaning validations implemented, which increased the process reliability.• Team's technical competencies assessment and development program leadership with target to have at least one back-up for each activity. This program reduced the risk of work interruption, as well as building a collaborative spirit and contributing to increased team motivation by learning.• Workflow and electronic repository system implementation for qualification and validation protocols. Review and approval time was reduced in 75%, documents became immediate available to be presented in audits.

Cosmopolis, São Paulo

Coordination of drug registration activities. Reporting to the Quality Manager. Team of two regulatory analysts.• Regulatory submissions and maintenance in 29 different countries, including England, Canada, Colombia, Argentina, China, Taiwan, Japan and the United States. • Training on requirements for Certification of Good Manufacturing Practices from different countries and site preparation to receive audits from several countries. • I escorted Brazilian regulatory authorities in international audits in the United States, Mexico and Spain.• I implemented the company ABL - Antibióticos do Brasil Ltda, from the social contract, Operating License, Certification of Good Manufacturing Practices and transfer of ownership of records.

Cosmopolis, São Paulo

Responsible for the preparation of dossiers of regulatory submission, record keeping, Licenses and Certification of Good Manufacturing Practices. Report to Records Coordinator.

Campinas

Responsible for regulatory dossiers preparation, submission and maintenace; operational licenses maintenace and Good Manufacturing Practices Certification for medicines, devices and medical equipment. Reporting to Training Manager.• Fresenius Medical Care company implementation including the social contract creation, operational License attainment, Good Manufacturing Practices certification and manufacturing authorizations transference.• Companies incorporation regularization: Maia de Almeida and Endomed as part of the Fresenius group.

Master Of Business Administration - Mba, Business/Commerce, General

Direito - Incompleto, Humanas

Bacharelado Em Farmácia, Industrial And Physical Pharmacy And Cosmetic Sciences