SENIOR QUALITY ASSURANCE ANALYST

Description

SENIOR QUALITY ASSURANCE ANALYST We are a Brazilian company with international presence, whose DNA is innovation! At Biolab, we believe that diverse teams build stronger and more transformative results. **We value inclusion and diversity across all our positions**. Therefore, we encourage applications from people with disabilities and from all identities, backgrounds, and origins**.** Within the Quality Assurance structure, you will be responsible for activities related to maintaining and enhancing the Quality Management System, contributing to continuous process improvement and ensuring compliance with applicable legal requirements and the certification standards adopted by the company. **WHAT WE EXPECT FROM YOU:** * Bachelor's degree in Pharmacy, Chemistry, or Engineering; * Proficiency in Microsoft Office (Word, Excel, and PowerPoint); * Familiarity with current pharmaceutical regulations; * Intermediate English (reading and writing); **MAIN RESPONSIBILITIES OF THIS POSITION BELOW:** * Modify, verify, and approve material lists in the ERP system; * Evaluate batch production histories and release batches for commercialization; * Develop and/or present quality indicators; * Develop and review Standard Operating Procedures; * Develop and/or review risk management documentation; * Review and approve Manufacturing and Packaging Instructions; * Evaluate change controls impacting your area of responsibility; * Manage the change control workflow and track action plans; * Investigate non-conformities / market complaints, monitor action plans, and manage the activity workflow; * Prepare Periodic Product Review reports; * Support and liaise with operational areas related to raw materials, packaging materials, and finished products (Logistics, PCP, Production, R&D, Quality Control, and Projects) on matters concerning Good Manufacturing Practices; * Develop/review validation protocols and oversee validation studies, hold-time assessments, qualification activities, and manage the associated workflows; * Deliver Good Manufacturing Practices training to employees; * Conduct audits and manage the self-inspection program, tracking action plans. * Prepare regulatory submission documentation. To learn more about us, visit www.biolabfarma.com.br and follow our social media channels. **Location****Employment Type****Work Model** Bragança Paulista, SP, BR Permanent CLT On-site