Key Responsibilities 1. Logistics Budget Estimate and calculate the logistics expense budget, prepare cost forecasts, and control expenses. 2. Shipment Arrangement Arrange shipments, set delivery schedules, monitor risks, and implement the transportation process. 3. FDA Submission Apply for FDA approval, prepare the required documents, and follow up on the approval process. 4. Delivery Operations Verify delivery terms in Supplier Contracts and Purchase Orders (PO) and follow up with suppliers to ensure timely delivery. Request shipping documents from suppliers in advance, review them, and coordinate to resolve any discrepancies. 5. Import License Apply for import licenses and follow up on the approval process. 6. Customs File Run Conduct file running at the customs office and submit clearance documents. Calculate customs duties and request budget approval. Calculate demurrage and detention fees with shipping lines and arrange payments. If necessary, estimate and request approval for penalty-related expenses. Inform relevant departments about updated regulations and new policies from customs and airport/port authorities. 7. Port Material Pickup Pick up goods from the port/airport and transport them to the designated location. If there is any damage or shortage, arrange necessary actions for delivery. Report and coordinate with relevant departments if there are clearance issues such as shortage, excess, or damaged goods. 8. Third Party Inspection Arrange third-party inspections, review inspection reports, and ensure shipments pass inspection before shipment. 9. Production Follow-Up Follow up on production progress according to the supply timeline and monitor material availability and output. 10. Supplier Payment Make down payments to suppliers according to the contract terms. Make final payments to suppliers according to the contract terms. 11. Warranty Period Monitor and handle claims and supplier service obligations during the warranty period. 12. Warehouse Handover Transport goods from the port to the warehouse. Upon receiving goods, verify quantity, batch numbers, and lot numbers before handing them over to the warehouse. Open and inspect the goods and obtain acceptance. If there are damages or shortages, contact the supplier and arrange replacement. Handle cases related to force majeure and losses/damages. Ensure acceptance after replacement of the materials.
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.
1. Market Research Collect market-related information from doctors, pharmacies, distributors, and consumers. Conduct research on pricing, competitors, demand changes, and overall market conditions. Ensure accuracy and confidentiality throughout the data collection process. Systematically store market research data and update it regularly in a timely manner. 2. Data Analysis & Market Insights Assist in identifying and analyzing market trends, customer needs, and key sales data. Prepare and present research findings so they can be applied to product positioning, pricing strategies, and market expansion. Verify the accuracy and completeness of research results and update them regularly. 3. Marketing Execution Assist in implementing marketing campaigns and promotional activities. Support in preparing marketing budgets for specific campaigns. Coordinate with relevant departments regarding promotional materials and marketing collaterals and assist in planning and implementation. Collaborate with media partners, associations, and external stakeholders to enhance brand awareness. 4. Digital Marketing Assist in implementing the company’s digital marketing activities, including social media management, website management, and online campaigns. Coordinate with vendors and agencies for digital content creation and online promotions and support the implementation process. Monitor and analyze digital marketing performance (reach, engagement, leads) and prepare regular reports. 5. Association & Event Participation Assist the manager in participating in business associations, meetings, seminars, and trade fairs. Build and maintain good professional relationships with hospitals, clinics, pharmacies, wholesale distributors, and relevant government organizations. 6. Reporting & Presentation Prepare and present market research and marketing performance reports with appropriate recommendations. Clearly present collected market information to the Manager, senior management, and relevant departments. Prepare dashboards, summaries, and visual presentations to support management decision-making. 7. Reporting Responsibilities Report back to Management / Head of Department (HOD) in a timely manner regarding the progress and status of assigned tasks and responsibilities.