Job Summary: A Pharmacist professional responsible for formulation development, pilot batch evaluation, regulatory documentation preparation, and production monitoring to ensure product quality and compliance. Key Highlights: 1. Development of formulations and pilot batch preparation 2. Preparation of regulatory registration documentation 3. Monitoring of pilot/industrial batch production Description: * Bachelor's degree in Pharmacy; * Computer literacy; * Intermediate English proficiency is desirable; * Knowledge of current Sanitary Legislation will be considered an advantage. * Conduct formulation development related to drug registration and post-registration activities, with low complexity and under supervision, through relevant literature research and pilot batch preparation (bench-scale testing) for projects under responsibility, aiming to ensure development quality. * Evaluate and discuss pilot batch approval based on obtained results via technical meetings to ensure development quality; * Contribute to meeting the development project schedule by executing tasks assigned to the Development area and following up with interfacing departments to guarantee adherence to proposed deadlines. * Prepare documentation arising from product registration and post-registration activities (change control, risk analysis, comparative tables, technical justifications, PATE, PGMP), to be submitted to the regulatory authority, through rigorous and detailed document review to ensure compliance with legal and technical requirements. * Perform cost and impact assessments regarding proposed changes, through careful evaluation of the entire process, formula, and materials to ensure alignment with the company's strategic objectives. * Monitor pilot and/or industrial batch production related to registered products and post-registration changes (optimizations and improvements) by overseeing all production stages, enabling generation of reports with conclusions. * Comply with standards and procedures through training and execution of related tasks to ensure product and company compliance with quality, health, safety, environmental systems, and regulatory authorities. 2512160202201868586
João Silva
Indeed · HR
João Silva
Indeed · HR
