Francisco Manoel Leal

Rua Dona Cleusa Ribeiro Lacerda, 60 E-Mail : adbx14@r.postjobfree.com

Ernestina Bernardes, Lagoa da Prata – MG

CEP: 35590-000 Contact: +55-37-999**-****

Area of Interest: Quality Assurance Management/ Production/ Quality Control and Project Manager

Qualifications

Significant and respected role in outstanding positions in the Quality area, working in multinational companies of the pharmaceutical and medical product sector.

Outstanding experience in the management of Quality Control and Assurance Department, designing and developing new strategies of action.

Responsible for technical advisory to clients, aiming at the improvement of their quality and technical support.

Experience in the development and implementation of quality standards and procedure manual, based on the GMP, ISO 9000, 13485 e 14001 standards for certification before certifying bodies.

Significant performance in a group of quality auditors in all Latina America.

Participated in construction projects of new units, responsible for the transfer of equipment and products.

Responsible for the Qualification and Certification program of Raw Material and Packaging Material Suppliers.

Responsible for the certification project before ANVISA of the first pharmaceutical industry of the state of ES.

Active participation and responsible for the certification before the FDA, European Community and Japan.

LANGUAGES: Fluent in English and Spanish.

Education

MBA in Quality Management - Universidade Federal Fluminense [Federal University]/RJ

Graduated in Industrial Chemistry with Technology Orientation - Fundação Souza Marques/RJ

Professional Experience

N Labor – January 2019 until nowadays

Technical Manager

Assignments and Responsibilities

• Provision of technical advisory services to companies that produce, import, distribute and store medicines and cosmetics, among other types of consumer products.

• Support to various types of activities in the area of Quality (Quality control, development of formulations, pharmaceutical study, quality internal audit, technical translations, assistance in technical response to requirements, etc.).

• Factory infrastructure project.

• Balancing production capacity;

• Good practice training.

• Internal audits

• Compliance with regulatory requirements of ANVISA.

• Implementation of good manufacturing practices;

• Cleaning validation;

• Process validation;

• Qualification of suppliers

• Transportation qualification

• Qualification of equipment installation, operation and performance

• Qualification of processes

• Support for inspections for GMP certification and sanitary permit

• Translations: English and Spanish

• Training

Pharmedice Manipulações Especializadas – May 2018 until Dec 2018

Technical Manager

Assignments and Responsibilities

Responsible for planning, organizing and controlling the manufacturing activities of the products, recommending policies and production programs

Analyze the investments needs for new equipment’s and process

Monitor and evaluating the production results

Search and analyze new production techniques, as well as the feasibility of their implementation

Coordinate the dispatch and distribution of products, to meet the requests of customers and institutions

Implementation of Quality System and increase of Quality Control of finished products, raw materials and packaging materials

Responsible for supporting, planning and operationalizing the transfer of production to a new unit

Fundação Ezequiel Dias (Funed) – June 2016 to July 2017

Industrial Director

Assignments and Responsibilities

• Responsible for planning, organizing and controlling the manufacturing activities of pharmaceutical and biotechnological products, formulating and recommending production policies and programs

• Analyze the need for investments in new equipment and machinery

• Monitor and evaluate production results

• Search and analyze new production techniques, as well as the feasibility of their implementation

• Coordinate the dispatch and distribution of products, in order to comply with the contracts of national programs for immunization, prevention and health care of the population

• Establish an exchange, with other institutions and companies to contribute to the health interests, making partnerships of technology transfer and knowledge

• Support the development of research and studies aiming at the expansion and improvement of the product line of its area of operation

FIOTEC – MOZAMBIQUE X BRAZIL – March 2013 until March 2014

Industrial Chemical (Technology Transfer of Anti-Retroviral Drugs for the unity of the Mozambican Medicines Company)

FIOTEC – MOZAMBIQUE X BRAZIL – March 2014 until June 2015

International Project Manager (Deputy Director of Operations): (Technology Transfer of Anti-Retroviral Drugs for the unity of the Mozambican Medicines Company)

Industrial Management

Manufacturing area management, planning and organization of the production line, leading work teams, defining production strategies with senior management.

Development projects of new products, cost control, resource optimization, ensuring quality of processes and products, keeping proper layout for the flow of production processes to meet the daily production volume, supplying the demand of commercial needs.

Definition of production priorities, negotiating stops for preventive maintenance, corrective and product testing. Participate in management meetings in order to share key information in the production area with the other managers. Budgeting areas based on the plan set by the company. Control of overhead costs to meet the budget of the area, searching for alternatives to reduce costs.

Performance monitoring and control of production through the analysis of indicators proposing plans and actions necessary to ensure compliance with the goals and objectives established in the strategic plan.

Identification, training and monitoring of the development of potential leaders within their area of expertise.

Monitoring compliance with the company's inventory policy, to the achievement of the monthly production volume target and avoid the finish goods breaks.

Implementation of Quality System

Support the development of key procedures and documentation for implementation of the Quality System, seeking certification from WHO.

Technical Training

Training of technical staff Control and Quality Assurance in their activities related to the areas of quality, validation and regulatory affairs

TECHNOLOGY TRANSFER

Support and coordination of local activities concerning the qualifications and validations of all equipment, facilities, products, methodologies of analysis on the areas of quality and production to meet the legal requirements of local legislation (Mozambique) and international (World Health Organization)

ST. JUDE MEDICAL – BH/MG – From 2003 to 2012

Quality System Manager

ISO 14001 Certification:

Definition of strategies; formation of work groups; definition of the site Representative; benchmarking with the parent company and other sites; negotiation with the certifying body, selection and definition of a consultant; definition and choice of a company to support and control legal requirements.

Transfers and qualification of equipment and products for new unit:

Definition of items and equipment to be transferred; establishment of the validation plan; definition of validation and transfer schedule; meeting with the group responsible for the transfer; FUP meetings and management of the new unit until its complete transfer.

Certifications of the new unit before the Certifying Bodies (ANVISA, FDA and CE Mark):

Definition of items and requirements; establishment of an action plan defining terms and persons in charge; follow-up and evaluation of the action plan; definition and follow-up of the support group for the inspection.

Definition of requirements and needs for the laboratory area (Microbiology and Physical-Chemical) of the new unit:

Definition of the equipment required and user’s requirements for the project; contact with suppliers and reception of proposals; planning and submission of the budget for approval.

Support to the international auditors (ANVISA) in the EUA and Costa Rica units:

Accompanying the auditor group during inspection; responsible for mediating and clarifying doubts and questions between the auditor team and the company team.

Development of new suppliers of Graphic Material, Refrigerators, Chemical Products and Chemical Analysis:

Survey of potential suppliers; certification audit; action plan follow-up; approval and qualification of new suppliers.

Support to the unit in Sao Paulo in obtaining the Good Storage and Distribution Practices Certificate before ANVISA:

Quality team training; development and follow-up of the action plan; internal audits; support and training for collaborators from other areas; follow-up of the certification inspection.

Certification of Nova Lima unit before the FDA (EUA), ISO 13485 (CE Mark) and Japan:

Establishment and monitoring the action plan; alignment of basic requirements and development, coordination and service to the inspections with the parent company’s quality area.

CELLOFARM IND. LTDA. – Vitória/ES - 2002

Quality Control Manager

Obtaining the company operation license before the local VISA:

Survey of requirements; organization of the work group; definition and follow-up of the action plan, monitoring the release inspection.

Formation and management of the Quality team:

Survey of needs; definition of recruiting strategy; evaluation and recruitment of collaborators; team training.

Regularization of the marketing license for drugs imported from the parent company (India):

Survey of non-conformities and items not complied with by the legislation; definition of outsourced laboratories for analysis of legislation compliance; survey of needs to perform in-house tests; regularization and fulfillment of pending issues before regulatory bodies.

SMITHKLINE BEECHAM DO BRASIL – Rio de Janeiro/RJ – from 1989 to 2002

Manager of Packaging Materials Quality Control and Suppliers Certification – 2000 to 2002

Quality Assurance Manager – 1993 to 2000

Head of Quality Control - 1989 to 1993

Development of new formulation and packaging material for Sal de Fruta Eno (100% use of national raw material and in-house manufacturing of bottles):

Replacement of imported raw materials (Tartaric Acid, Citric Acid and Sodium Carbonate); replacement of packaging materials (glass for PVC and afterwards for PET); coordination and follow-up of stability tests.

Development of the new manufacturing process "Emulsão de Scott":

Study of the formulation used; survey of the main possibilities of improvement; development of new formulation; performance of the pilot batches; follow-up of the stability tests; implementation and follow-up of the manufacturing process with the production.

Implementation of the microbiological tests to the products manufactured:

Survey of the key microbiological tests required to the products manufactured; evaluation and purchase of the equipment for the performance of the tests; evaluation of the area for the laboratory assembly; team recruiting, training and coordination.

Development of new formulas of products (cosmetics and disinfectants):

Reception of projects from the marketing department; survey and evaluation of new formulations; development of raw materials with the suppliers; manufacturing of pilot batches; performance and follow-up of stability tests; follow-up of the first batches manufacturing in industrial scale with the production area.

Creation and coordination of the packaging development area:

Feasibility study; equipment acquisition; team recruiting and training in association with suppliers.

Creation and coordination of the qualification program and supplier’s certification:

Survey of applicable legislation; creation, discussion and unification of the qualification/audit check list with ABIFARMA multidisciplinary team; training of in-house auditor team; discussion of the process with key suppliers; development of a schedule and leadership of audits.

Participation in the Quality auditor group in the Latin America plants (Mexico, Venezuela, Chile, Costa Rica, Porto Rico, Panama, and Argentina):

Participation as Leader Auditor and qualified auditor.

Development of aluminum International Supplier with 40% reduction to the cost of the material used in Brazil and subsequent coordination and implementation in the other Latin America units:

Evaluation of specifications; evaluation and audit of the new supplier; coordination of stability tests; approval of the first batches used.

Participation as the representative of the Quality area in the program to reduce the number of graphic material (cartridges) suppliers (53 to 7) in Latin America plants:

Survey and unification of the specifications used; audit on the suppliers; follow-up and evaluation of the changes performed.

Participation in the development of the company Quality Manual for the Latin America plants:

Survey and discussion of key requirements; meeting and alignment with the teams of the countries that did not participate in the discussion meetings (Mexico and Venezuela); Manual review and approval.

Participation in the support and assistance group of the new unit (Jacarepaguá) in order to comprise the three units currently in use (Cordovil, Engenho de Dentro and Guadalupe):

Alignment of requirements and equipment of the new lab; survey of the facility needs of the lab area; manufacturing and support; preparation, definition and training of the new team; coordination of the laboratories transfer.

Extracurricular Courses

Lead Auditor

SUP. Labor Safety

Quality System / Quality Assurance

Material Management / Production Control Planning

Headship and Leadership

Supplier Qualification

Team Building

People Management

Business Management

Coaching

Negotiation

Project Management

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