Description
Are you looking to work in the pharmaceutical sector at an innovative and expanding company?
**Responsibilities and Duties**
Experience in computerized system and spreadsheet validation;
Desirable experience in qualification of production equipment;
Review and develop validation plans and validation schedules; Draft User Requirement Specifications (URS);
Develop risk assessments for qualifications and validations;
Develop qualification and validation protocols;
Train personnel involved in qualifications and validations;
Perform qualifications and validations in accordance with corresponding protocols and applicable current regulations;
Collect samples and record information related to qualifications / validations;
Conduct and analyze supplier qualification for qualification services;
Monitor service providers for qualifications and validations;
Evaluate results obtained during qualification and validation tests;
Draft corresponding qualification and validation reports;
Monitor and update qualification and validation schedules;
Monitor change control definitions and related actions;
Identify solutions to correct deficiencies that may arise in equipment, utilities, devices, or machinery during qualifications and/or validations;
Monitor deviation investigations;
Participate in internal quality self-inspections and audits;
Participate in regulatory agency inspections when requested;
Perform Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT);
Provide support and perform other professional activities related to and inherent to the position, as directed and/or requested by the immediate supervisor.
**Requirements and Qualifications**
Bachelor’s degree completed. Academic background: Degree in Pharmacy or related fields;
English and Spanish – from Basic to Intermediate level;
Join Our Team!
Since 1988, Farmarin has been a pioneer in nephrology, standing out in the production of Polyelectrolyte Concentrates for Hemodialysis (PCHD) in Brazil. Initially established to serve several hemodialysis clinics in São Paulo, Farmarin has grown exponentially over the years, keeping pace with the increasing demand for its products.
In 2000, we relocated our facilities to Guarulhos, where we began industrial-scale production to serve both domestic and international markets. Currently, we are investing in new products for the hospital sector in Brazil.
In 2012, Farmarin was acquired by Medifarma S.A., Peru’s largest pharmaceutical manufacturer and market leader since 1964\. Since then, Medifarma has made significant investments in Farmarin, enhancing our infrastructure, state-of-the-art technology, and specialized human capital, always adhering to its high standards of quality and development of new product lines.
Today, Medifarma operates 7 manufacturing plants, occupying over 70\.000m² across 4 countries in South America and Europe, exporting to 15 countries. Our portfolio includes a wide range of pharmaceutical products, such as injectable and oral medications—including oncology drugs, antibiotics, anticoagulants, anti\-inflammatory agents—and large- and small-volume parenteral solutions, among others.
Join this success and innovation story! Join our team and contribute to a healthier and more promising future.