Pharmaceutical Development Analyst

Description

**?‍ ️** **Responsibilities and Duties:** 1\. Draft/Review pharmacotechnical development reports related to post-registration activities. 2\. Draft/Review the Initial History. 3\. Draft Production Technical Sheets for laboratory batches and placebos related to post-registration activities and request their manufacturing. 4\. Prepare laboratory batches and placebos related to post-registration activities and place them in primary stability studies. 5\. Provide laboratory batches, placebos, and pilot batches to requesting departments. 6\. Draft/Review Pilot Master Formulas and Initial Release Formulas of products and collect signatures from responsible personnel. 7\. Monitor the weekly production scheduling records for production lines at Hipolabor Units I and III. 8\. Provide Production Technical Sheets for laboratory and pilot batches to SPCP, including calculations of active pharmaceutical ingredient (API) assay and moisture content. 9\. Monitor the manufacturing of laboratory, pilot, and industrial batches related to post-registration activities at Units I and III, drafting the Product Manufacturing Monitoring Report. 10\. Evaluate suppliers of materials related to post-registration activities—designated by the Systemic Quality Assurance Department—based on pre-formulation test results, laboratory batch data, placebo data, pilot batch data, and industrial batch data. 11\. Monitor deviations, non-conformities, RTs (Root Cause Analyses), and RCMs (Risk Control Measures). 12\. Monitor manufacturing stages of outsourced products related to post-registration activities. 13\. Draft/Review Risk Assessments for legacy products. 14\. Complete PATE forms. 15\. Perform document reviews within deadlines, ensure compliance with operational procedures and Good Manufacturing Practices (GMP), and report any non-conformities to supervisors. 16\. Identify, analyze, and propose corrective actions for anomalies arising from redevelopment processes. 17\. Monitor the first industrial batches following post-registration changes. 18\. Support the production department regarding quality deviations and product stability. 19\. Conduct training on quality documents. Other duties as assigned by management. **?** **Requirements and Qualifications:** Education: Completed undergraduate degree in Pharmacy with active registration at the regional pharmacy council; Knowledge of quality tools, regulations, and standards; Experience: In pharmaceutical industry routine and pharmaceutical development; Basic English. **?** **Additional Information:** Working hours: Monday to Friday, 07:00–17:00