Senior Technical Documentation Analyst

Description

Accord Farmacêutica, a market leader in generics and biosimilars for oncology, hematology, and critical care therapies, is seeking a Senior Technical Documentation Analyst to join our team and contribute to the excellence of our processes. **What will be your day-to-day responsibilities?** * Draft protocols and reports for analytical method validation of products—including assay, dissolution, and degradation products—in accordance with internal procedures and applicable legislation; * Critically review raw data generated during analytical method validation of products—including assay, dissolution, and degradation products—in accordance with internal procedures and applicable legislation; * Initiate non-conformities when required and support related investigations; * Assist in developing spreadsheets for result calculations; * Prepare analytical data sheets for pharmaceutical equivalence and comparative dissolution profiles in accordance with internal procedures and applicable legislation; * Provide technical/analytical support and training to other laboratory analysts; * Issue documents for national regulatory inspections, supporting laboratory supervision; * Conduct literature searches using company-provided tools (Internet and/or reference databases); * Report results in compliance with Good Laboratory Practices (GLP); * Update and draft SOPs—Standard Operating Procedures—pertaining to quality control department activities. Requirements: Bachelor’s degree in Pharmacy or Chemistry; Knowledge of: * Analytical validation and technical documents (specifications and methods); * Pharmaceutical equivalence and dissolution profiles; * Good Documentation Practices (GDP); * Regulations related to Good Analytical Laboratory Practices (GALP); * RDC 166/2017; RDC 749/2022; and RDC 31/2010; * Analytical equipment such as HPLC, GC, LC, among others; Prior experience in pharmaceutical equivalence laboratories, research and development, and/or quality control laboratories. Intermediate technical English (reading and writing). MS Office suite.