SENIOR ANALYTICAL DEVELOPMENT ANALYST

Description

Job Summary: Professional to guide analysts, develop and evaluate technical dossiers, and support management in registration and post-registration documentation for products, aiming to meet the company's goals. Key Highlights: 1. Brazilian company with international presence and innovation in its DNA. 2. Values inclusion and diversity across all positions. 3. Focus on technical documentation and regulatory compliance. We are a Brazilian company with international presence, bringing innovation into our DNA! At Biolab, we believe diverse teams build stronger and more transformative results. **We value inclusion and diversity in all our positions**. Therefore, we encourage applications from people with disabilities and from all identities, backgrounds, and origins**.** In the Technical Documentation team, provide technical guidance to team analysts, develop and technically evaluate technical dossiers, and support management in controlling processes and tasks related to submission documentation for registration and post-registration of products subject to sanitary surveillance, in compliance with legislation and technical guidelines, aiming to fully meet the company's goals. **WHAT WE EXPECT FROM YOU:** * Bachelor's degree in Pharmacy, Chemistry, or Chemical Engineering; * Knowledge of physicochemical bench analysis and instrumental analysis by HPLC and GC, UV and IR spectrophotometers; * Knowledge of RDC 964; * Knowledge of RDC 166/17 and its guidelines; * Desired knowledge of RDC 31 and IFA evaluation; * Knowledge of predictive software; * Forced degradation studies; * Risk analysis; * Strong expertise in evaluating and justifying mass balance. **SEE BELOW THE MAIN RESPONSIBILITIES FOR THIS POSITION:** * **Conduct** dissolution profile studies by applying analytical methodologies and evaluating obtained results, aiming to **obtain** information supporting product development and characterization; * **Develop** and **conduct** solubility and dissolution development study protocols and reports, complying with requirements established in ANVISA RDC No. 31, aiming to **fulfill** regulatory requirements and **contribute** to product development; * **Conduct** stability studies by developing protocols, performing analyses, and issuing reports according to RDC No. 318/19, aiming to **evaluate** maintenance of product quality throughout the shelf life; * **Analyze** results of physicochemical and stability studies by applying analytical techniques and interpreting laboratory data, aiming to **ensure** result reliability and **fulfill** quality requirements; * **Verify** compliance of laboratory activities by applying Good Laboratory Practice legislation and guidelines, aiming to **maintain** process integrity and **fulfill** regulatory requirements. To learn more about us, visit www.biolabfarma.com.br and follow our social media channels. **Location****Employment Type****Work Model** São Paulo, SP, BR Full-time CLT On-site