Key Responsibilities 1. Production & Compounding Oversee and perform sterile (IV) and non-sterile compounding and other specialty formulations. Ensure batch records, formulas, and SOPs are followed precisely. Manage preparation, labeling, packaging, and dispensing of products. Operate and maintain automated compounding equipment, laminar airflow hoods, isolators, and other production tools. 2. Product Development & Formulation Research & Design: Develop, validate, and scale-up formulations for sterile (e.g., IV bags, syringes, ophthalmic) and non-sterile (e.g., creams, gel, suspensions, capsules) compounded medications. Stability & Compatibility: Determine beyond-use dates (BUDs) based on physicochemical stability studies, sterility considerations, and literature references (e.g., stability references). Assess drug-drug and drug-container compatibilities. Master Formulation Record (MFR) Creation: Author and maintain definitive Master Formulation Records detailing:Qualitative and quantitative composition (exact weights, measures, calculations). Specific ingredients (grades, sources). o Step-by-step compounding procedures with critical process parameters. o Required equipment and containers/closures. In-process and final product quality control specifications (pH, osmolality, weight, sterility, endotoxin testing). Documentation: Maintain a formulation database and ensure all developed recipes are properly documented, approved, and archived 3. Production, Compounding & Scaling Execute compounding based on approved formulations, ensuring precise adherence to MFRs. Scale laboratory-based formulations to batch production sizes while maintaining stability, sterility, and homogeneity. Troubleshoot formulation and process issues during production (e.g., precipitation, pH drift, viscosity changes). 4. Quality Assurance & Compliance Implement and enforce quality control procedures for all products. Perform and document environmental monitoring. Conduct routine inspections of cleanrooms, equipment, and materials. Oversee end-product testing and sterility assurance. 5. Documentation & Record Keeping Maintain accurate batch records, compounding logs, and quality assurance documentation. Review and approve production records for completeness and compliance. Manage documentation for recalls, deviations, and corrective actions (Corrective Action and Preventive Action ). 6. Inventory & Supply Management Monitor and order pharmaceuticals, supplies, and raw materials for production. Ensure proper storage and handling of ingredients, especially controlled substances and hazardous materials. Coordinate with purchasing and inventory teams to avoid shortages. 7. Staff Training & Supervision Train and supervise pharmacy technicians, interns, and support staff in aseptic technique and production procedures. Schedule and allocate staff for production workflows. Conduct competency assessments and ongoing education. 8. Safety & Risk Management Enforce safety protocols for handling hazardous drugs (HDs) and hazardous materials. Ensure use of appropriate personal protective equipment (PPE) and engineering controls. Investigate and report adverse events, errors, or quality issues. 9. Process Improvement Optimize production workflows for efficiency and accuracy. Evaluate and implement new technologies, equipment, or formulations. Participate in continuous quality improvement (CQI) initiatives.